MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D11X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81251170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the gamma nail has migrated upwards, while the femoral head including neck has collapsed downward, even though the gamma4 nail was in place." a revision surgery was required.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the gamma nail has migrated upwards, while the femoral head including neck has collapsed downward, even though the gamma4 nail was in place." a revision surgery was required.
Additional Manufacturer Narrative
The reported failure mode adverse impact to patient - postoperatively could be confirmed since medical intervention was required but reported event of nail migration could not be confirmed based on x-ray images provided.The explant of implant in question consequently took place.The date of explant was stated as following (b)(6) 2025 after the initial treatment with reported unknown g4 lag screw in combination with reported gamma4 trochanteric nail on (b)(6) 2025.However, the provided details and x-ray images available for the current case were forwarded to a medical expert for review and statement: his comments (excerpts): from the x-rays provided to me via the email, i cannot confirm a nail migration.The distal screw still seems to be in the exact same position.The collapse of the femoral head on day 1 cannot be confirmed either since no evidence is provided on per-operative positioning of the nail, the lagscrew and the quality of reduction.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.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 labeling 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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D11X170MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22742581
• Report Number: 0008031020-2025-01334
• Device Sequence Number: 20716357
• Product Code: HSB
• UDI-Device Identifier: 07613327478877
• UDI-Public: 07613327478877
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81251170S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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: 78 YR
• Patient Sex: Female