MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D11X360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As per reported by the customer: "almost nine months after implantation of the nail together with a cerclage, a nail fracture occurred without directly associated trauma (recent falls between (b)(6) 2024 and (b)(6) 2025 not excluded).Re-operation with change to head prosthesis with trochanteric support plate.Also all risks associated with re-operation.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history for the reported 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.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.It is probable the mentioned recent falls may have played a role in the reported event.However, in the absence of any additional documentation (such as medical records), it cannot be confirmed.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As per reported by the customer: "almost nine months after implantation of the nail together with a cerclage, a nail fracture occurred without directly associated trauma (recent falls between (b)(6) 2024 and (b)(6) 2025 not excluded).Re-operation with change to head prosthesis with trochanteric support plate.Also, all risks associated with re-operation.".
Event or Problem Description
As per reported by the customer: "almost nine months after implantation of the nail together with a cerclage, a nail fracture occurred without directly associated trauma (recent falls between (b)(6) 2024 and (b)(6) 2025 not excluded).Re-operation with change to head prosthesis with trochanteric support plate.Also, all risks associated with re-operation.".
Additional Manufacturer Narrative
Corrections: please refer to sections d9 (the device was returned) and h6 (method, results and conclusion codes).The reported event could be confirmed since the device was returned broken.The device inspection revealed the following: the nail broke at the level of the lag screw hole.The breakage surface exhibits clear signs of a fatigue fracture.Fatigue zones with a smooth surface and progression lines are visible.Material deformation can be seen on the edge of the hole on the distal end which most likely had created the starting point of the fracture at lateral.A more polished and shiny area on the distal portion of the nail is visible, which is likely due to post-breakage rubbing between the broken surfaces.Altogether, the nail breakage was most probably caused by fatigue due to high mechanical load, indicating the nail was exposed to continuous high load over a longer period of time.A review of the device history for the reported 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.Based on investigation, the root cause was attributed to a patient related issue.The device has broken in a fatigue manner, most probably related to the recent falls experienced by the patient.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D11X360MM 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: 22473559
• Report Number: 0008031020-2025-01073
• Device Sequence Number: 7904956
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: (01)07613252273837(11)240208(17)290131(10)K1A33A8
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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: 34251360S
• Device Lot Number: K1A33A8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 10/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/21/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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 Sex: Unknown