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	10/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "while drilling t2agt distal oval hole, the drill was going through the screw hole but the drill was not advancing properly, and the drill tip broke off when the physician changed direction and advanced the drill.The tip of the drill remained in the patients body.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "while drilling t2agt distal oval hole, the drill was going through the screw hole but the drill was not advancing properly, and the drill tip broke off when the physician changed direction and advanced the drill.The tip of the drill remained in the patients body.".

• 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 KIEL; 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: 23415769
• Report Number: 0008031020-2025-02007
• Device Sequence Number: 9084654
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: (01)07613327350241(17)350531(10)K1322F7
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23514236S
• Device Lot Number: K1322F7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: 17 YR
• Patient Sex: Male