MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, RIGHT D11X420MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84251420S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "on tuesday (b)(6) 2025 i received a message to come in and support a case to remove a broken gamma nail.The surgeon doing the revision case was boopalan ramasamy.The plan was to remove the broken nail, use the synthees ria reamer to try and prevent any infection and then re-fixate the fracture with a smith and nephew nail.Original case date for implantation of the gamma nail was (b)(6) 2025.".
Event or Problem Description
As reported: "on tuesday 25/11/25 i received a message to come in and support a case to remove a broken gamma nail.The surgeon doing the revision case was boopalan ramasamy.The plan was to remove the broken nail, use the synthees ria reamer to try and prevent any infection and then re-fixate the fracture with a smith and nephew nail.Original case date for implantation of the gamma nail was (b)(6) 2025.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The returned device was visually examined and found to be fractured at the regions corresponding to the lag screw sections.Damage was noted around both the locking screw hole and the oblong hole, which appears consistent with misdrilling.Prominent misdrilling marks were visible on both fracture segments, extending from the posterior to the lateral web.Evidence of deformation was observed on the lateral and posterior sides of the proximal and distal sides, respectively, likely resulting from cyclic loading during functional use.Misdrilling plays a critical role in initiating cracks through the notching effect, thereby compromising the device's structural integrity.The fracture pattern indicates a multifactorial failure mechanism.Fatigue features, such as rest lines, were observed on the posterior web of the proximal fragment, correlating with progressive fatigue failure.In contrast, the anterior web displayed a shiny and smooth fracture surface, indicative of a sudden brittle-type failure.The received locking screw is broken into two fragments as well; the broken surface indicates that the breakage pattern is fatigue and brittle in nature, indicating that the screw broke in a sudden manner cause from nail breakage sudden increase in load.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 the above investigation, the breakage of nail contributes to multifactorial fatigue and is brittle in nature.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the implant failure no conclusive statement can be provided, because key clinical information (e.G.X-rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports) is missing.The root causes in such cases are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, RIGHT D11X420MM 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: 23869632
• Report Number: 0008031020-2025-02206
• Device Sequence Number: 11916878
• Product Code: HSB
• UDI-Device Identifier: 07613327478785
• UDI-Public: (01)07613327478785(17)340228(10)K1A4119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 84251420S
• Device Lot Number: K1A4119
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG