MAUDE Adverse Event Report: Stryker GmbH IMN SCREWS - LOCKING SCREW D5X60MM; Screw, fixation, bone

Catalog Number	23605060S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the customer reported medial migration of the lag screw in a left gamma 4 nail.The patient has been revised." update (b)(6) 2026: "a broken distal screw was noticed too.".

• Brand Name: IMN SCREWS - LOCKING SCREW D5X60MM
• Common Device Name: Screw, fixation, bone
• 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 ; +1(201)831-5000
• MDR Report Key: 25782917
• Report Number: 0008031020-2026-00840
• Device Sequence Number: 9625940
• Product Code: HWC
• UDI-Device Identifier: 07613327368574
• UDI-Public: 07613327368574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23605060S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male