MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965045S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	02/14/2025
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: "the nail, fitted to a patient following a polyfragmented stepped fracture of the right femoral shaft on (b)(6) 2022 (patient significantly overweight 130kg), broke and had to be removed.In the chronology of events, we can report the following: (b)(6) 2022: displacement of the distal locking screws during market resumption (b)(6) 2023: complete breakage of the distal locking screws, telescoping of the fracture site with the distal part of the nail being driven into the medial condyle of the right knee (b)(6) 2024: incomplete breakage of the proximal part of the gamma long nail and scheduling of a reoperation for nail extraction.(b)(6) 2025: nail extraction.".
Additional Manufacturer Narrative
Please note the correction to h6 device code.A device inspection was not possible since the affected device was not returned and the provided documentation could not confirm this specific locking screw was broken.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the nail, fitted to a patient following a polyfragmented stepped fracture of the right femoral shaft on (b)(6) 2022 (patient significantly overweight 130kg), broke and had to be removed.In the chronology of events, we can report the following: (b)(6) 2022: displacement of the distal locking screws during market resumption (b)(6) 2023: complete breakage of the distal locking screws, telescoping of the fracture site with the distal part of the nail being driven into the medial condyle of the right knee.(b)(6) 2024: incomplete breakage of the proximal part of the gamma long nail and scheduling of a reoperation for nail extraction.(b)(6) 2025: nail extraction.".

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X45 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: 22803498
• Report Number: 0008031020-2025-01365
• Device Sequence Number: 21072906
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: (01)04546540202505(11)220531(17)270430(10)K047398
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 18965045S
• Device Lot Number: K047398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 130 KG