Académique Documents
Professionnel Documents
Culture Documents
Fanelli Magellan
Suture Retriever
Fanelli System
Instruments
Graft Tensioning
Boot
Double Bundle
Aimers
Facilitates suture
retrieval during PCL and
ACL reconstruction
Promotes reproducible
graft passage
Patient Positioning
The patient is placed on the operating
room table in the supine position, and
after satisfactory induction of anesthesia,
the operative and nonoperative lower
extremities are carefully examined. A
tourniquet is applied to the upper thigh of
the operative extremity, and that extremity is
prepped and draped in a sterile fashion.
When allograft tissue is used, it is prepared
prior to bringing the patient into the
operating room. Autograft tissue is
Bio-Core
Interference Screw
Resorbable interference
screw made of
LactoSorb L15
resorbable copolymer
Ability to be filled
with autograft or
allograft bone
Surgical Technique
Figure 1
Figure 2
Initial Incision
Figure 3
Figure 5
Figure 4
Surgical Technique
Figure 6
Figure 7
Figure 8
Figure 10
Figure 9
Surgical Technique
Figure 12
Figure 11
Figure 15
Figure 13
Figure 14
Figure 16
Surgical Technique
Figure 17
Figure 20
Figure 18
Figure 21
ACL Reconstruction
With the knee in approximately 70 90 of flexion, the
ACL tunnels are created using the Fanelli PCL/ACL
guide. The arm of the Fanelli PCL/ACL guide enters the
knee joint through the inferior medial patellar portal
(Figure 21). The bullet of the drill guide contacts the
anterior medial proximal tibia externally at a point
approximately 1 cm proximal to the tibial tubercle
midway between the posterior medial border of the
tibia, and the tibial crest anteriorly. The guide wire is
drilled through the guide to emerge through the center
of the stump of the ACL tibial footprint. A standard
cannulated reamer is used to create the tibial tunnel
(Figure 22). Reaming debris is evacuated, and the tunnel
edges are chamfered and rasped.
Figure 22
Surgical Technique
Figure 23
Figure 24
Figure 26
Figure 25
Figure 27
Surgical Technique
Figure 28
Figure 29
Surgical Technique
Figure 30
Figure 31
References
PCL and Multiple Knee Ligament Injury Text Books by Gregory C. Fanelli, M.D.
Posterior Cruciate Ligament Injuries: A Practical Guide To Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag,
New York, 2001.
The Multiple Ligament Injured Knee. A Practical Guide to Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag,
New York, 2004.
PCL and Multiple Knee Ligament Injury Related Peer Reviewed Articles by Gregory C. Fanelli, M.D.
Gregory C. Fanelli, M.D., Posterior Cruciate Ligament Injuries In Trauma Patients. Arthroscopy 9(3) pp. 291294, 1993.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig Edson, P.T.: Current Concepts Review. The Posterior Cruciate Ligament:
Arthroscopic Evaluation And Treatment. Arthroscopy Vol. 10, No. 6. pp. 673688, December, 1994.
Gregory C. Fanelli, M.D., Craig J. Edson, P.T./A.T.C.: Posterior Cruciate Ligament Injuries In Trauma Patients: Part II. Arthroscopy Vol.
11, No. 5. pp. 526529, 1995.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Arthroscopically Assisted Combined ACL/PCL
Reconstruction. Arthroscopy, Vol. 12, No.1., pp. 514, 1996.
Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Arthroscopically Assisted PCL/Posterior Lateral
Complex Reconstruction. Arthroscopy, Vol. 12, No. 5, 1996.
Raymond M. Bleday, M.D., Gregory C. Fanelli, M.D., Bradley F. Giannotti, M.D., Craig J. Edson, M.H.S., P.T., A.T.C., Thomas A Barrett,
M.D.: Instrumented Measurement of the Posterolateral Corner. Arthroscopy, Vol. 14, No. 5: 489494, 1998.
Gregory C. Fanelli, M.D., Daniel D. Feldmann, M.D., The Dislocated/Multiple Ligament Injured Knee. Operative Techniques In
Orthopaedics, 9(4):112, 1999.
Gregory C. Fanelli, M.D., Daniel D Feldmann, M.D., Management of Combined Anterior Cruciate Ligament/Posterior Cruciate
Ligament/Posterolateral Complex Injuries of the Knee. Operative Techniques In Sports Medicine, 7(3):143149, 1999.
Gregory C. Fanelli, M.D.: Combined Anterior and Posterior Cruciate Ligament Injuries: The Multiple Ligament Injured Knee.
Sports Medicine And Arthroscopy Review, 7(4):289295, 1999.
Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: Complications of Posterior Cruciate Ligament Reconstruction. Sports Medicine
And Arthroscopy Review, 7(4):296302, 1999.
Gregory C. Fanelli, M.D.: Treatment of Combined Anterior Cruciate Ligament-Posterior Cruciate Ligament-Lateral Side Injuries of
the Knee. Clinics In Sports Medicine,19(3):493502, 2000.
Gregory C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C., David R. Maish, M.D.: Management of Combined ACL/PCL injuries.
Techniques In Orthopaedics,16(2):157166, 2001.
Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: Complications in posterior cruciate ligament and posterolateral complex
surgery. Operative Techniques In Sports Medicine. April, 9(2);9699, 2001.
Gregory C. Fanelli, M.D.: Surgical Treatment of the Acute and Chronic ACL/PCL/Medial Side/Lateral Side Injuries of the Knee.
Sports Medicine and Arthroscopy Review, September, 9(3), 2001.
Gregory C. Fanelli, M.D., Roger V. Larson, M.D.: Practical Management of Posterolateral Instability of the Knee. Arthroscopy, 18(2)
{February, Suppl 1}:18, 2002.
Gregory C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C.: Arthroscopically Assisted Combined ACL/PCL Reconstruction. 210 year
Follow-up. Arthroscopy,18(7):703-714, 2002.
Gregory C. Fanelli, M.D.: Arthroscopic Posterior Cruciate Ligament Reconstruction: Transtibial Tunnel Technique. Surgical
Technique and 210 Year Results. Arthroscopy, 18(9):4449, (December Supplement 2), 2002.
Gregory C. Fanelli, M.D.: Surgical Treatment of ACL-PCL-Medial Side-Lateral Side Injuries of the Knee. Operative Techniques in
Sports Medicine, 11(4):263274, 2003.
Gregory C. Fanelli, M.D.: Systematic Approach to the Multiple Ligament Injured Knee. Arthroscopy; 19(3037): (December
Supplement 1), 2003.
Gregory C. Fanelli, M.D., Craig J Edson, M.S., P.T./A.T.C.: Combined Posterior Cruciate Ligament Posterolateral Reconstruction
with Achilles Tendon Allograft and Biceps Femoris Tendon Tenodesis: 210 year Follow-up. Arthroscopy, 20 (4): 339345, 2004.
Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D.: Complications in Posterior Cruciate Ligament Reconstruction. Sports Medicine and
Arthroscopy Review, 12 (3): 196201, 2004.
Bergfeld JA, Cooper DE, Fanelli GC, Harner CD: Round Table Discussion. Reconstructing the PCL: Tips and Techniques.
Orthopaedics Today, 24 (12): 1,1621, 2004.
Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Current Concepts: The Multiple Ligament Injured
Knee. Arthroscopy, 21 (4): 471486, 2005.
Gregory C. Fanelli, M.D.: Surgical Reconstruction for Acute Posterolateral Injury of the Knee. Journal of Knee Surgery, 18 (2):157
162, 2005.
Fanelli GC, Edson CJ, Orcutt DR, Harris JD, Zijerdi D.: Treatment of Combined ACL-PCL-MCL-PLC Injuries of the Knee. Journal of
Knee Surgery, 18 (3):240248, 2005.
Gregory C. Fanelli, M.D.: Surgical Treatment of Lateral Posterolateral Instability of the Knee Using Biceps Femoris Tendon
Procedures. Sports Medicine and Arthroscopy Review, February, 14(1), 2006.
Fanelli GC, Harris JD: Surgical Treatment of Acute Medial Collateral Ligament and Posteromedial Corner Injuries of the Knee.
Sports Medicine and Arthroscopy Review, May, 14(2), 2006.
Fanelli GC, Harris JD. : Late MCL (Medial Collateral Ligament) Reconstruction. Techniques In Knee Surgery, (In Press), 2006.
Package Inserts
Arthrotek, Inc.
A Wholly Owned Subsidiary of Biomet, Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581 USA
01-50-1058
Date: 07/04
4.
5.
6.
7.
8.
9.
10.
11.
Care is to be taken to assure adequate soft tissue fixation at the time of surgery.
Failure to achieve adequate fixation through improper positioning or placement of
the device can contribute to a subsequent undesirable result.
The use of appropriate immobilization and postoperative management is indicated
as part of the treatment until healing has occurred.
Correct handling of implants is extremely important. Do not modify implants. Do
not notch or bend implants. Notches or scratches put in the implant during the
course of surgery may contribute to breakage. Intraoperative fracture of screws can
occur if excessive force (torque) is applied while seating bone screws.
Do not heat LactoSorb Interference Screws by any means prior to implantation.
DO NOT USE if there is loss of sterility of the device. Discard and DO NOT USE opened
or damaged devices, and use only devices that are packaged in unopened and
undamaged containers.
DO NOT USE where a permanent implant is indicated.
DO NOT USE with other resorbable implant materials.
Adequately instruct the patient. Postoperative care is important. The patients ability
and willingness to follow instructions is one of the most important aspects of
successful soft tissue management. Patients affected with senility, mental illness,
alcoholism, and drug abuse may be at a higher risk of device or procedure failure. These
patients may ignore instructions and activity restrictions. The patient is to be instructed
in the use of external supports that are intended to immobilize the repair site and limit
weight bearing or load bearing. The patient is to be made fully aware and warned that
the device does not replace normal healthy tissue, and that the device can break, bend
or be damaged as a result of stress, activity, load bearing, or weight bearing. The patient
is to be made aware and warned of general surgical risks, possible adverse effects, and
to follow the instructions of the treating physician. The patient is to be advised of the
need for regular postoperative follow-up examination as long as the device remains
implanted.
PRECAUTIONS
Instruments are available to aid in the accurate implantation of internal fixation devices.
Intraoperative fracture or breaking of instruments has been reported. Surgical instruments
are subject to wear with normal usage. Instruments, which have experienced extensive use
or excessive force, are susceptible to fracture. Surgical instruments should only be used for
their intended purpose. Arthrotek recommends that all instruments be regularly inspected
for wear and disfigurement.
POSSIBLE ADVERSE EFFECTS
1. Infection can lead to failure of the procedure.
2. Neurovascular injuries can occur due to surgical trauma.
3. Bending, fracture, loosening, rubbing, and migration of the implant may occur as a
result of excessive activity, trauma, or load bearing.
4. Implantation of foreign materials can result in an inflammatory response or allergic
reaction.
5. Inadequate healing which may lead to breakage of the implant or failure of the graft
material.
6. Pain, discomfort, or abnormal sensation due to the presence of the device.
7. Necrosis of the bone or tissue.
STERILITY
Arthrotek resorbable implants are sterilized by exposure to Ethylene Oxide (ETO) Gas. Do not
resterilize. Do not use past expiration date.
STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURES
GREATER THAN 120F OR 49C.
Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order
of a physician.
Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc.,
P.O. Box 587, Warsaw, IN 46581 USA, Fax: 574-372-1683.
Manufacturer:
Biomet Manufacturing Corp.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0587
Authorized Representative:
Biomet U.K., Ltd
Waterton Industrial Estates
Bridgend, South Wales
CF31 3XA, U.K.
0086
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that
date. To obtain a current package insert, please use the contact information provided herein.
3. Inadequate fixation at the time of surgery can increase the risk of loosening and
migration of the device or tissue supported by the device. Sufficient bone quantity and
quality are important to adequate fixation and success of the procedure. Bone quality
must be assessed at the time of surgery. Adequate fixation in diseased bone may
be more difficult. Patients with poor quality bone, such as osteoporotic bone, are at
greater risk of device loosening and procedure failure.
4. Implant materials are subject to corrosion. Implanting metals and alloys subjects them
to constant changing environments of salts, acids, and alkalis that can cause corrosion.
Putting dissimilar metals and alloys in contact with each other can accelerate the
corrosion process that may enhance fracture of implants. Every effort should be made
to use compatible metals and alloys when marrying them to a common goal, i.e., screws
and plates.
5. Correct handling of implants is extremely important. Do not modify implants. Do not
notch or bend implants. Notches or scratches put in the implant during the course
of surgery may contribute to breakage. Intraoperative fracture of screws can occur if
excessive force (torque) is applied while seating bone screws.
6. Do not use excessive force when inserting suture anchors. Excessive force (long hard
hammer blows) may cause fracture or bending of the device. When encountering hard
cortical bone, predrill with a 3/32 or 1/8 inch drill prior to inserting suture anchors.
7. Adequately instruct the patient. Postoperative care is important. The patients ability
and willingness to follow instructions is one of the most important aspects of successful
fracture management. Patients effected with senility, mental illness, alcoholism, and
drug abuse may be at a higher risk of device or procedure failure. These patients may
ignore instructions and activity restrictions. The patient is to be instructed in the use of
external supports, walking aids, and braces that are intended to immobilize the fracture
site and limit weight bearing or load bearing. The patient is to be made fully aware and
warned that the device does not replace normal healthy bone, and that the device can
break, bend or be damaged as a result of stress, activity, load bearing, or weight bearing.
The patient is to be made aware and warned of general surgical risks, possible adverse
effects, and to follow the instructions of the treating physician. The patient is to be
advised of the need for regular postoperative follow-up examination as long as the
device remains implanted.
PRECAUTIONS
Do not reuse implants. While an implant may appear undamaged, previous stress may have
created imperfections that would reduce the service life of the implant. Do not treat with
implants that have been even momentarily placed in a different patient.
Instruments are available to aid in the accurate implantation of internal fixation devices.
Intraoperative fracture or breaking of instruments has been reported. Surgical instruments
are subject to wear with normal usage. Instruments, which have experienced extensive use or
excessive force, are susceptible to fracture. Surgical instruments should only be used for their
intended purpose. Arthrotek recommends that all instruments be regularly inspected for wear
and disfigurement.
If device contains MaxBraid suture, refer to manufacturer package insert for
further information.
POSSIBLE ADVERSE EFFECTS
1. Nonunion or delayed union, which may lead to breakage of the implant.
2. Bending or fracture of the implant.
3. Loosening or migration of the implant.
4. Metal sensitivity, or allergic reaction to a foreign body.
5. Pain, discomfort, or abnormal sensation due to the presence of the device.
6. Nerve damage due to surgical trauma.
7. Necrosis of bone or tissue.
8. Inadequate healing.
9. Intraoperative or postoperative bone fracture and/or postoperative pain.
STERILITY
Arthrotek internal fixation implants are typically supplied sterile and are sterilized by
exposure to a minimum dose of 25kGy of gamma radiation or by Ethylene Oxide Gas (ETO) if
device contains MaxBraid PE suture. If supplied sterile, do not resterilize the implant.
If not supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.
Do not sterilize UHMWPE implants using steam autoclaving methods. Do not use implants after
expiration date.
Pre-VacuumSteam (HI-VAC) -- wrapped or unwrapped
Temperature
270-275 F (132-135C)
Exposure Time
5 Minutes
Drying Time
8 Minutes
Since Arthrotek is not familiar with individual hospital handling methods, cleaning methods
and bioburden, Arthrotek cannot assume responsibility for sterility even though the guideline
is followed.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
1. Correct selection of the implant is extremely important. The potential for success in
soft tissue to bone fixation is increased by the selection of the proper type of implant.
While proper selection can help minimize risks, neither the device nor grafts, when used
are designed to withstand the unsupported stress of full weight bearing, load bearing
or excessive activity.
2. The implants can loosen or be damaged and the graft can fail when subjected to
increased loading associated with nonunion or delayed union. If healing is delayed,
or does not occur, the implant or the procedure may fail. Loads produced by weight
bearing, and activity levels may dictate the longevity of the implant.
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that
date. To obtain a current package insert, please use the contact information provided herein.
Ordering Information
Bio-Core Interference Screw
905635
905636
905637
905638
905639
905640
905641
905642
905643
905644
905645
905646
7 x 20mm
7 x 25mm
7 x 30mm
8 x 20mm
8 x 25mm
8 x 30mm
9 x 20mm
9 x 25mm
9 x 30mm
10 x 20mm
10 x 25mm
10 x 30mm
904215
904219
15mm
19mm
905401
905402
905403
905404
905405
905406
905407
6.5 x 25mm
6.5 x 30mm
6.5 x 35mm
6.5 x 40mm
6.5 x 45mm
6.5 x 50mm
6.5 x 55mm
904530
904535
904540
904545
904550
904555
904560
904565
904570
6.5 x 30mm
6.5 x 35mm
6.5 x 40mm
6.5 x 45mm
6.5 x 50mm
6.5 x 55mm
6.5 x 60mm
6.5 x 65mm
6.5 x 70mm
904630
904632
904634
904636
904638
904640
904642
904644
904646
904648
904650
904652
904654
904656
904658
904660
6.5 x 30mm
6.5 x 32mm
6.5 x 34mm
6.5 x 36mm
6.5 x 38mm
6.5 x 40mm
6.5 x 42mm
6.5 x 44mm
6.5 x 46mm
6.5 x 48mm
6.5 x 50mm
6.5 x 52mm
6.5 x 54mm
6.5 x 56mm
6.5 x 58mm
6.5 x 60mm
905418
18mm
904414
904418
904420
14mm
18mm
20mm
904428
18mm
P.O. Box 587, Warsaw, IN 46581-0587 800.348.9500 ext. 1501 2006 Arthrotek, Inc. All Rights Reserved
web site: www.arthrotek.com eMail: arthrotek@arthrotek.com
Form No. Y-BMT-979/071506/K
I N V E N T I N G
T H E
F U T U R E
O F
A R T H R O S C O P Y