MAUDE Adverse Event Report: Stryker GmbH IMN Instruments - Locking Drill D4.2x360mm; Orthopedic manual surgical instrument

Catalog Number	23514236S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "initially, when drilling on the proximal side of the transverse screw, the drill bit came into contact with the nail; the surgeon immediately checked and adjusted the position of the device using a lateral view, and after the drilling was re-started, the proximal screw was inserted without any problems.Next, when drilling the distal elliptical hole, there was again interference with the nail.As with the proximal screw, the surgeon checked and corrected the position using a lateral view, then drilled again; however, the medial cortex was extremely hard, and the drill bit broke when pressure was applied.As the drill bit remained embedded in the bone and was deemed impossible to extract, the surgery was completed while the broken drill bit was left in the patient's bone.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: IMN Instruments - Locking Drill D4.2x360mm
• 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: 50061362
• Report Number: 0008031020-2026-00914
• Device Sequence Number: 18478964
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: 07613327350241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190402
• 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): 07/28/2026

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: 23514236S
• Device Lot Number: K19CC1F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/28/2026
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 220 LB