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Model Number 04.037.162S
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)
Event Date 01/02/2019
Event Type  malfunction  
Event Description
On [date redacted], the patient, who had fallen at home, underwent: intramedullary nail fixation, right hip intertrochanteric fracture, closed reduction right distal radius with splinting. The right lower extremity was prepped and draped in the usual sterile fashion. Prior to skin incision, varying degrees of traction with external, followed by internal, rotation was completed to achieve closed reduction of the intertrochanteric fracture. A skin incision was made at the proximal aspect of the greater troch. The guidewire for the synthes tfn nail system was introduced into the proximal femur. After confirming views on both ap and lateral, the proximal femur was reamed with the entry reamer, this followed by passing the ball-tip guidewire down to the distal end of the femur. Careful sequential reaming was completed up to 12. 5 mm reamer with good cortical chatter. An 11 mm diameter nail was chosen x 420 mm length. The nail was assembled on the back table and then impacted into position. After the nail was seated to an appropriate depth, a guidewire was taken into the center-center position of the femoral head. Please note that he did have some deformity at the femoral head anteriorly, causing me to place the guidewire slightly more posteriorly than perfectly centered on the lateral view. This was followed by reaming the bone for a 115 mm helical blade. The helical blade was then placed. The nail was locked for rotation and the fracture was compressed. This was followed by placing 1 distal interlocking screw. Final fluoroscopic images were obtained. The irrigation was completed, the wounds were closed in layers, and then sterile dressings were placed. The patient was awakened from anesthesia and taken to the recovery room in satisfactory condition. Approximately eight months later, the patient underwent removal of hardware: history of present illness: had a hip fracture approximately 8 to 10 months ago that was fixed with intramedullary (im) nail. He has had worsening pain when he ambulates as well as difficulty walking. The pain was quite severe. He went to physical therapy and had pain medications. He had modified lifestyle and still having discomfort. Subsequent ct scan showed that he had a non-union intertrochanteric fracture with moderate hip arthrosis. At this time, he is going to have this removed and converted to a total hip arthroplasty. Postoperative diagnosis: right intertrochanteric hip non-union. Procedures performed: conversion to right total hip arthroplasty with removal of hardware. Implants: right link, size 18x180mm tapered, revision femoral stem with a neutral body and a +4mm 40mm ceramic femoral head, a biomet g7 size 58 acetabular component with 58/40 polyethylene liner. Notes from the operative report: "the distal incision was utilized. The screw found without difficulty and the distal locking screw removed. The proximal portion of the hip was dislocated, and the proximal portion of the nail was obtained and plate removed. The hip was then re-dislocated and neck cut was performed. " there were no complications.
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Manufacturer (Section D)
35 airport rd.
horseheads NY 14845
MDR Report Key8451115
MDR Text Key139815236
Report Number8451115
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 03/21/2019,03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.162S
Device Catalogue Number04037162S
Device Lot NumberH533125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2019
Device Age8 MO
Event Location Hospital
Date Report to Manufacturer03/26/2019
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