MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, RIGHT D11X380MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84251380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by the rep: "date of original fix (b)(6) 2024.Date of implant failure (b)(6) 2025.Planned for revision.Implants will be returned.Royal victoria hospital belfast for primary and revision surgery." further information from rep: "no events as such, presented with hip pain.No fall as far as we know.".
Event or Problem Description
As reported by the rep: "date of original fix (b)(6) 2024.Date of implant failure (b)(6) 2025.Planned for revision.Implants will be returned.(b)(6) for primary and revision surgery." further information from rep: "no events as such, presented with hip pain.No fall as far as we know.".
Additional Manufacturer Narrative
Please note the corrections to d9 and h6 device codes.The reported event could be confirmed based on details provided, only.Images available revealed both distal locking screws to be broken.Due to missing device, a physical evaluation was impossible.Furthermore, images provided were forwarded to an hcp for review and statement his comments ¿ excerpts: ¿both distal screws are broken indeed.The healing status 8 months after surgery is most probably a non-union, there is little/some callus formation, but the fracture lines are still obvious, which is not what you would expect 8 months after surgery¿ axial overload had led to continuous stresses and a significant weakening of the nail in the area of the lag screw thru hole, followed by the fatigue fracture after an implantation duration of approx.8 months, which is also supported by both failed locking screws.The screw is not designed to take over the intended use of nail in case of a non-intact situation occurs.The affected nail is designed to withstand the normal loads during the implantation period, i.E., the implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.In case such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.Due to the broken nail, there was increased force transmission to the locking screw, which then finally broke as a result of overload.Based on the above the screw breakage is rather related to patient conditions and has to be classified as patient-patient factors issue.No discrepancies verified for the nail based on the available details.Adverse effects are clearly listed in the ifu and as pointed out ¿revision and additional surgery may be a consequence of these complications¿ with information available no deficiency of the screw in question could be verified.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: GAMMA4 - LONG NAIL, RIGHT D11X380MM 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: 22950337
• Report Number: 0008031020-2025-01446
• Device Sequence Number: 8453589
• Product Code: HSB
• UDI-Device Identifier: 07613327479553
• UDI-Public: (01)07613327479553(17)340531(10)K1BCAC6
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 84251380S
• Device Lot Number: K1BCAC6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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: 84 YR
• Patient Sex: Female