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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP TFN-ADVANCE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES (U.S.A.) LP TFN-ADVANCE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.160S
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 02/27/2018
Event Type  malfunction  
Event Description
Notes from the history and physical examination (h&p): patient was walking and noted audible "pop" to right hip accompanied by severe pain, has continued to have right hip pain since. Was initially not able to bear weight, however, has been weight bearing since with pain and walker. Currently complains of aching right hip pain, located at right groin, worse with weight bearing, improved with rest and narcotic pain medication. Notes from the operative report: the patient on sustained a right closed comminuted subtrochanteric femur fracture, which was treated by me with open reduction and internal fixation. He has since gone on to have a nonunion of the fracture site, which resulted in a failed implant as well as pain and inability to bear weight. Description of procedure: we then prepped and draped the patient's right lower extremity in usual sterile fashion. We then recreated the patient's initial incisions extending both lateral incision over the greater trochanter as well as the lateral incision over the vastus ridge approximately 2 cm in each direction. This was created with a #10 blade and carried down through skin and subcutaneous tissue. We then used a rongeur to remove the proximal portion of the nail which had fractured. We then used the cross starting device to remove the helical blade through a separate incision. We then recannulated the patient's remaining portions of the nail distally, removed the distal interlocking screw, and then used a hook to ball tip guidewire to hook on to the distal portion of the nail and then mallet it out. We then reamed sequentially to a size 14. 5 mm reamer. The appropriate size nail was then measured. We then performed an open bone biopsy through the greater trochanter corticotomy. This was done with a pituitary rongeur and these tissues were sent for permanent section. In addition, we collected some of the fibrous tissue which had been placed around the broken portion of the patient's previous implant and sent this for cultures. We then inserted the new implant. Prior to placing the screw retrograde up into the femoral neck and head, we increased the traction to create additional valgus of the fracture to facilitate healing. We then secured this into place with the compression screw as well as the main lag screw and then set this in a static position. Two distal interlocking screws were then placed into static locking positions with perfect circle technique.
 
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Brand NameTFN-ADVANCE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES (U.S.A.) LP
1210 ward ave
west chester PA 19380
MDR Report Key8369590
MDR Text Key137123397
Report Number8369590
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.160S
Device Catalogue Number04037160S
Device Lot NumberH356290
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2019
Event Location Hospital
Date Report to Manufacturer02/26/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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