MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965040S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "gamma nail is broken at the entry point of the femoral neck screw.Metal removal necessary." on the x-ray attached in the intake, we see that one of the distal locking screw is also broken.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section d6a implant date.Although initially only a broken nail was reported and confirmed, physical examination revealed that one of the two locking screws was also broken.It was determined that the locking screw with lot code k1bc384 was broken approximately in the center of the shaft.Broken surface presents feature of a fatigue fracture.The intended use of a locking screw is not to take over the intended use of the temporary nail implant in the event of a nail fracture.According to the damage verified and since the nail broke in a fatigue fracture due to axial overload the biomechanical stresses on the whole construct increased and thus, broken locking screw was resulting.For further details and full context please refer to main investigation under complaint mfr # (b)(4).A review of the device history for the broken locking screw lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.According to available information a deficiency of the locking screw was not verified.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "gamma nail is broken at the entry point of the femoral neck screw.Metal removal necessary." on the x-ray attached in the intake, we see that one of the distal locking screw is also broken.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø5X40 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20665451
• Report Number: 0009610622-2024-00910
• Device Sequence Number: 8231261
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: (01)04546540202499(17)290430(10)K1BC384
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 18965040S
• Device Lot Number: K1BC384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG