MAUDE Adverse Event Report: Stryker GmbH IMN SCREWS - ADVANCED LOCKING SCREW D5X75MM; Rod, Fixation, Intramedullary And Accessories

Catalog Number	23615075S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2026
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: "an advanced locking screw was implanted into a t2 alpha retrograde nail from lateral to medial direction ~(b)(6) 2026.Final ii shots show the screw was placed into the nail as per op tech.(b)(6) 2026.Patient had to be reoperated to remove the advance locking screw as it has migrated medially with the head of the screw touching the nail.".

• Brand Name: IMN SCREWS - ADVANCED LOCKING SCREW D5X75MM
• 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 ; +1(201)831-5000
• MDR Report Key: 25724660
• Report Number: 0008031020-2026-00815
• Device Sequence Number: 9440131
• Product Code: HSB
• UDI-Device Identifier: 07613327381467
• UDI-Public: (01)07613327381467(17)340430(10)K1B9EFE
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 23615075S
• Device Lot Number: K1B9EFE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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