MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965040S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As per reported by the customer: "almost nine months after implantation of the nail together with a cerclage, a nail fracture occurred without directly associated trauma (recent falls between 07/2024 and 03/2025 not excluded).Re-operation with change to head prosthesis with trochanteric support plate.Also all risks associated with re-operation." 09/16/2025 - upon product return, one locking screw was found broken.
Event or Problem Description
As per reported by the customer: "almost nine months after implantation of the nail together with a cerclage, a nail fracture occurred without directly associated trauma (recent falls between (b)(6) 2024 and (b)(6) 2025 not excluded).Re-operation with change to head prosthesis with trochanteric support plate.Also, all risks associated with re-operation." 09/16/2025 - upon product return, one locking screw was found broken.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned broken.The device inspection revealed the following: the screw broke at the level of the threads.The breakage surface is predominantly flat and smooth, which is characteristic of a fatigue fracture.Altogether, the screw breakage was most probably caused by fatigue due to high mechanical load, likely related to the nail breakage itself.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 investigation, the root cause was attributed to a patient related issue.The device has broken in a fatigue manner, most probably related to the recent falls experienced by the patient.If any additional information is provided, the investigation will be reassessed.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X40 MM
• 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: 23300719
• Report Number: 0008031020-2025-01781
• Device Sequence Number: 10028266
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: (01)04546540202499(17)290131(10)K19D047
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 18965040S
• Device Lot Number: K19D047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2024
• 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: 86 YR
• Patient Sex: Female