MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, TI GAMMA3 Ø10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600100S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient was converted from a gamma trochanteric nail to a total hip due to cut-out of the lag screw through the femoral head.Rep provided explant pictures and revision usage, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
A device inspection was not possible since the affected device was not returned and no other evidences, like x-rays which would confirm the event, were provided for investigation.The received pictures were reviewed.The pictures show the implants, the nail with corresponding set screw, the lag screw and one locking screw, directly after explantation.Based on the pictures the reported functional issue cannot be evaluated, also the catalog and lot numbers of the involved devices cannot be confirmed as they are either not visible on the implants or the quality of the picture is too low.The provided implant card only lists the devices that were implanted during the revision surgery.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labelling did not indicate any abnormalities.Indications of material, manufacturing or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient was converted from a gamma trochanteric nail to a total hip due to cut-out of the lag screw through the femoral head.Rep provided explant pictures and revision usage, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: LAG SCREW, TI GAMMA3 Ø10.5X100MM
• 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: 21200629
• Report Number: 0008031020-2025-00216
• Device Sequence Number: 8285256
• Product Code: HSB
• UDI-Device Identifier: 04546540374943
• UDI-Public: 04546540374943
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 03/26/2025

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: 30600100S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 57 YR
• Patient Sex: Unknown