MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - FREEHAND DRILL D4.2X185MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514218S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported by the customer: "patient operated on for left tibia fracture.Single-use distal locking drill broke inside the patient.Impossible to retrieve the piece.".
Event or Problem Description
As reported by the customer: "patient operated on for left tibia fracture.Single-use distal locking drill broke inside the patient.Impossible to retrieve the piece.".
Additional Manufacturer Narrative
Please note correctio to d9 (product available to stryker).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IMN INSTRUMENTS - FREEHAND DRILL D4.2X185MM
• 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 ; 2018315000
• MDR Report Key: 24692114
• Report Number: 0008031020-2026-00482
• Device Sequence Number: 10004800
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: 23514218S
• Device Lot Number: KU197293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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: Unknown