MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D4X28 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18964028S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
During t2ph surgery, the screw placed in the most distal oval hole protruded anteriorly beyond the bone.As the event occurred after screw insertion into the distal round hole, the screw placed in the distal oblong hole was removed from the body.Since one screw remains inserted distally, the physician assessed that stable fixation had been achieved.Upon inspection of the targeting device at the japan distribution center, it was confirmed that the drill interferes with the nail.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D4X28 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 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: 25138086
• Report Number: 0008031020-2026-00633
• Device Sequence Number: 9480414
• Product Code: HSB
• UDI-Device Identifier: 04546540202338
• UDI-Public: (01)04546540202338(17)300831(10)K1482CD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• 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): 06/29/2026

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: 18964028S
• Device Lot Number: K1482CD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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
• Patient Sex: Unknown