MAUDE Adverse Event Report: STRYKER GMBH T2 - NAIL HOLDING SCREW, HUMERUS 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060163
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "breaking of the locking pins on a diaphyseal humeral nail." additional feedback received: "how was the event detected? during surgery, when it became impossible to continue the procedure.When inserting the humeral nail, the nail was placed on the nail holder, the screw was tightened correctly, and the nail anchor was checked.The anvil was positioned to impact the nail.A rotational movement was performed to align the nail and position it correctly.During the rotation, a crack was heard, with abnormal mobility between the nail holder and the nail.Did the event occur during the procedure? if yes: was the procedure completed correctly? yes, during the procedure, it was completed correctly.Was there any impact on the patient?/any clinical consequences for the patient? no impact on the patient.Was the procedure delayed? if yes: by how much time (in minutes)? the procedure was delayed by 25-30 minutes while we fetched an ancillary device to extract the nail and reposition another one.Was additional medical intervention necessary? no.".

• Brand Name: T2 - NAIL HOLDING SCREW, HUMERUS 10 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; 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: 24300025
• Report Number: 0008031020-2026-00141
• Device Sequence Number: 13303296
• Product Code: LXH
• UDI-Device Identifier: 04546540196095
• UDI-Public: 04546540196095
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18060163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown