MAUDE Adverse Event Report: Stryker GmbH IMN Instruments - Locking Drill Sleeve, Long; Orthopedic manual surgical instrument

Catalog Number	23514280
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "when inserting the proximal locking drill sleeve into the device, it was mistakenly inserted from lateral to medial instead of from medial to lateral as instructed, resulting in an unnecessary skin incision.The error was noticed before drilling was performed.The procedure was then continued using the correct technique, drilling from medial to lateral, and the surgery was completed without further issue.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: IMN Instruments - Locking Drill Sleeve, Long
• 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 ; +1(201)831-5000
• MDR Report Key: 50158517
• Report Number: 0008031020-2026-01011
• Device Sequence Number: 10576407
• Product Code: LXH
• UDI-Device Identifier: 07613327368178
• UDI-Public: 07613327368178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23514280
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 08/06/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male