MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965055S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 6 months, the nail was removed since it broke off at the cephalic screw part.9/9/2025 - upon product return additional devices were received including one broken locking screw.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Although initially only a broken nail was reported and confirmed, physical examination revealed that one of the two locking screws was also broken.It was determined that the locking screw with lot code k158b17 was broken approximately in the center of the shaft.Broken surface presents feature of a fatigue fracture.The intended use of a locking screw is not to take over the intended use of the temporary nail implant in the event of a nail fracture.According to the signs of damage verified the biomechanical stresses on the whole construct increased and thus, broken locking screw was resulting.For further details and full context please refer to main investigation under complaint (b)(4).A review of the device history for the broken locking screw 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.According to available information a deficiency of the locking screw was not verified.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that after 6 month, the nail was removed since it broke off at the cephalic screw part.9/9/2025 - upon product return additional devices were received including one broken locking screw.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X55 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: 23219780
• Report Number: 0008031020-2025-01665
• Device Sequence Number: 9774803
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: (01)04546540202529(17)280531(10)K158B17
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 18965055S
• Device Lot Number: K158B17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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