MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, RIGHT D12X380MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84252380S
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported gamma 4 nail broke.Therefore, replacement surgery is scheduled for on (b)(6).Mobilization instructions from the surgeon: it was reported that partial weight-bearing was permitted after three weeks of immobilization.Activity level and behavior of patient: it is considered likely to be high because the patient works in a physically demanding job.The patient was compliant with instructions from surgeon.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported gamma 4 nail broke.Therefore, replacement surgery is scheduled for (b)(6).Mobilization instructions from the surgeon: it was reported that partial weight-bearing was permitted after three weeks of immobilization.Activity level and behavior of patient: it is considered likely to be high because the patient works in a physically demanding job.The patient was compliant with instructions from surgeon.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned nail is found broken which is also confirmed by the provided x-rays.The provided x-rays show fractured bone and the fractured nail broken from proximal web.However, the immediate post-operative x-ray after surgery and follow up x-rays are missing.The device inspection revealed the following: the nail was received and found broken from its proximal web.Stress bearing points are clearly visible in the medial region of distal fragment, indicating that excess compression forces were acting on the nail post-operatively.Apart from this, the surface characteristics of the fractured surface of distal fragment are lost due to excess contact with lag screw and other broken fragment.Proximal fragment of the broken nail shows signs of misdrilling i.E.The chamfer is damaged, and the portion is rubbed shiny due to contact with the drill.This misdrilling most likely contributed to enable the crack initiation from lateral anterior region due to notching effect.Further, fine lines of rest are clearly visible in the anterior portion of proximal fragment pointing towards a fatigue failure of the material due to repetitive cyclic loading and finally the catastrophic failure occurred as indicated by the uneven, rough portion in the posterior region when the implant was completely unable to withstand the applied 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.No product related issue could be detected during the performed investigation of the returned device.The implant ultimately failed to withstand the applied force, resulting in material overload and fatigue failure.Based on the information provided, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, RIGHT D12X380MM 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 ; 2018315000
• MDR Report Key: 24474976
• Report Number: 0008031020-2026-00250
• Device Sequence Number: 18537234
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 84252380S
• Device Lot Number: K1A4DAB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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: 52 YR
• Patient Sex: Male
• Patient Race: Asian