MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D11X400MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85251400S
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a broken gamma 4 nail has been explanted in (b)(6) area hospital, (b)(6).
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a broken gamma 4 nail has been explanted in (b)(6) hospital.
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg).The reported event could be confirmed, since the returned nail is found broken although the provided x rays do not show fractured bone and the broken nail and it was not feasible to obtain hcp evaluation with the quality of x rays being provided.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 and bending forces were acting on the nail post-operatively.Distal 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.The fracture surfaces are predominantly irregular shiny plastically deformed regions observed on portions of the fracture surface may be attributable to post-fracture rubbing/contact between separated implant fragments after failure.Fracture surface examination demonstrates an identifiable crack initiation site with a limited adjacent region showing possible fatigue progression features.However, these features occupy only a small portion of the total fracture surface.Most of the fracture surface exhibits irregular morphology without extensive rest-line formation, suggesting rapid fracture of the remaining portion.Surgical timeline of the events which is missing here would have further cemented these observations.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, LEFT D11X400MM 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: 24508105
• Report Number: 0008031020-2026-00363
• Device Sequence Number: 21361184
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 85251400S
• Device Lot Number: K1272B6
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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