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 Codes	Fall (1848); Pain (1994)
Date of Event	02/21/2026
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: "removal of a broken long gamma 4 nail (at the cervical screw) in situ, requiring the fitting of a hip prosthesis.The nail had been fitted on (b)(6) 2025." on 20-mar-2026, additional information received: it was detected via an x-ray of the hip and pelvis in the emergency department.The x-ray was performed on a patient who had been experiencing pain and weakness in the lower limb that had gradually developed over the past 5 days.(the patient had undergone surgery for a transfemoral fracture of the femur in (b)(6) 2025.) a new operation was required to remove the broken nail and implant a hip prosthesis.
Event or Problem Description
As reported: "removal of a broken long gamma 4 nail (at the cervical screw) in situ, requiring the fitting of a hip prosthesis.The nail had been fitted on (b)(6)2025." 20-mar-2026 - additional information received: it was detected via an x-ray of the hip and pelvis in the emergency department.The x-ray was performed on a patient who had been experiencing pain and weakness in the lower limb that had gradually developed over the past 5 days.(the patient had undergone surgery for a transfemoral fracture of the femur in (b)(6) 2025.) a new operation was required to remove the broken nail and implant a hip prosthesis.16-apr-2026 - additional information received: o how and when did the patient become aware of the event? 73-year-old patient presenting with progressive right hip pain for 5 days.Fell on (b)(6)2026 without loss of consciousness or trauma.Diagnosed with a nail fracture in the emergency department on (b)(6)2026.
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 was 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.Based on the investigation, the root cause was attributed to a patient-related issue.The event was most likely caused by the reported patient fall, which resulted in nail breakage.However, additional documentation (e.G.X-rays) would have been required to enable a more detailed and precise root cause determination.If the device is returned or if any additional information is provided, the investigation 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 GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24710385
• Report Number: 0008031020-2026-00488
• Device Sequence Number: 6088473
• Product Code: HSB
• UDI-Device Identifier: 07613327478785
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 84251420S
• Device Lot Number: K1BAEAE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 08/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/27/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 118 LB