MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23330938S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail was returned broken as reported.The device inspection revealed the following: the received nail was completely broken in the web of the proximal hole at distal part of the nail.Plastic deformation, shiny areas and rough surfaces with smooth sections can be observed.The breakage was most likely initiated from the lateral side in a fatigue manner (evident by lines of rest) and broke instantaneously from the other side due to high tension and loading over time.The formation of a shiny surface was caused due to gradual rubbing of the separated parts and locking screw before the nail finally broke.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.The broken nail was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, the implantation date is unknown and neither x-rays, nor operation report, nor information about patient activity was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue caused by high loads did lead to the breakage of the device.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "broken t2 alpha femur nail.All parts removed when revised.".
Event or Problem Description
As reported: "broken t2 alpha femur nail.All parts removed when revised.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X380MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20625153
• Report Number: 0009610622-2024-00901
• Device Sequence Number: 12625859
• Product Code: HSB
• UDI-Device Identifier: 07613327286496
• UDI-Public: (01)07613327286496(11)220817(17)320731(10)K069820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 23330938S
• Device Lot Number: K069820
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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