MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X320MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251320S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the gamma3 nail broke.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the gamma3 nail broke.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned nail could be confirmed based on the catalog and the lot numbers marked.The nail broke at the lag screw hole in two parts.Both parts have been returned.Evidence of fatigue could be seen on the surface of the breakage.This can be stated based on the lines of rest clearly visible on the anterior side of the nail, which are a classic indication of a fatigue fracture.According to the observations made, the fatigue fracture had its origination in the lateral side of the anterior portion of the lag screw hole.Signs of a secondary sudden "catastrophic" brittle fracture were observed on the posterior side of the device.Evidence of misdrilling is visible on the posterior side of the nail, both inside and outside the lag screw hole.The shiny area on the nail¿s exterior surface, caused by friction, suggests that there was likely an initial unsuccessful attempt to insert the lag screw, during which the screw was misaligned with the nail.This misaligned drilling and lag screw insertion created a chamfer like edge on the lateral posterior side of the hole, weakening the construct.It must be noted, nonetheless, that the fatigue fracture was the main cause of the implant's failure.The misdrilling most probably accelerated the breakage of an already weakened nail.Material deformation (bearing points) can be observed on the edge of the lag screw hole.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw, associated with the breakage of the nail.This statement is confirmed by the damage observed on the shaft of the lag screw.It should be noted that the exact root cause of the breakage could not be definitively determined.Additional information, such as x-ray images, patient medical records, and details of post-operative activities, would have been required for a conclusive assessment.As previously mentioned, the misdrilling likely contributed to the breakage by facilitating or accelerating fracture development.Nevertheless, fatigue remains the primary cause of the failure, although its underlying origin could not be established.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.If more information is provided, the case will be reassessed.

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, LEFT D11X320MM 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: 23076717
• Report Number: 0008031020-2025-01576
• Device Sequence Number: 9719474
• Product Code: HSB
• UDI-Device Identifier: 07613252274261
• UDI-Public: (01)07613252274261(17)291031(10)K1E7573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 35251320S
• Device Lot Number: K1E7573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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; Other
• Patient Sex: Unknown