MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84251420S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by the rep: gamma 4 revision case, due to a nonunion and implant breakage.
Additional Manufacturer Narrative
Correction - please refer to d1, d4 catalog #, d4 lot #, d9 - the device was returned for evaluation, g1 reporting contact, h6 (method & results) codes.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The return nail underwent a visual inspection, during which it was found to be broken into two fragments at the level of the lag screw hole.The microscopic inspection reveals lines of rest, indicating that the fracture was initiated in a fatigue manner.The material damage from miss-drilling may have weakened the device, contributing to the breakage, which is evident from the shiny marks on the lateral side.The other end suggests a sudden fracture in a brittle manner, which resulted from the fatigue fracture.Additionally, heavy deformation marks are visible at the load-bearing section, indicating that the nail was subjected to severe loads.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, we can conclude that the nail breakage occurred due to fatigue.Miss-drilling could potentially contribute to nail breakage as it affects the load-bearing capacity of the nail, making it more prone to failure.Additionally, while it is known that the patient was active with nonunion, without further radiographs or medical records, it is not feasible to determine the exact root cause of the issue failure.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported by the rep: gamma 4 revision case, due to a nonunion and implant breakage.

• Brand Name: LONG NAIL, RIGHT GAMMA4 Ø11X420MM X 125°
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21399345
• Report Number: 0008031020-2025-00298
• Device Sequence Number: 9345725
• Product Code: HSB
• UDI-Device Identifier: 07613327478785
• UDI-Public: (01)07613327478785(17)340228(10)K1A4D91
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 84251420S
• Device Lot Number: K1A4D91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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; Required Intervention
• Patient Sex: Unknown