MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2331-1242S

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Implanted in patient.

Event Description

The representative was provided a picture of an x-ray showing a t2 alpha greater troch nail with the distal locking screw backing out.Surgeon's text states: "why is it that the locking distal screws backed out but the regular screw did not?" no revision was reported for the patient at this time.

Manufacturer Narrative

The reported event was confirmed with the provided x-ray.Review of device history, x-ray, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.A device inspection was not possible since the affected device was still implanted.X-ray image was provided and reviewed by an hcp.In his opinion and in this case "the distal position of the als compared to the non-locking screws may end up with a longer lever arm and contribute to the loosening of the screw." based on investigation and provided medical statement it could not be excluded that the reported event is related to patient factors contributed by the kind of treatment.In case essential information becomes available we reserve the right to reopen the case for investigation and to assess a new root cause.

Event Description

The representative was provided a picture of an x-ray showing a t2 alpha greater troch nail with the distal locking screw backing out.Surgeon's text states: "why is it that the locking distal screws backed out but the regular screw did not?" no revision was reported for the patient at this time.

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 12X420MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10140067
• MDR Text Key: 195465926
• Report Number: 0009610622-2020-00284
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327284461
• UDI-Public: 07613327284461
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2331-1242S
• Device Catalogue Number: 23311242S
• Device Lot Number: K076B6A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 92