MAUDE Adverse Event Report: STRYKER GMBH IMN INSTRUMENTS - LOCKING DRILL D4.2X360MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514236S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2025
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: "drill 1: the surgeon mistook the short nail for a long nail and proceeded to drill into a screw hole that the short nail did not have.The drill tip was broken and the tip remains in the patient's body, but there are no plans to remove it.Drill 2: when drilling into the proximal screw hole, the patient's medullary cavity was narrow and the nail flexed, resulting in inaccurate targeting, which caused the drill to contact the nail and break off.The tip does not remain in the patient's body.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence 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.However, from the event description, it clearly looks like a user related issue since mistargeting occurred due to selection of incorrect nail initially resulting in the breakage of drill.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "drill 1: the surgeon mistook the short nail for a long nail and proceeded to drill into a screw hole that the short nail did not have.The drill tip was broken and the tip remains in the patient's body, but there are no plans to remove it.Drill 2: when drilling into the proximal screw hole, the patient's medullary cavity was narrow and the nail flexed, resulting in inaccurate targeting, which caused the drill to contact the nail and break off.The tip does not remain in the patient's 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: 22473563
• Report Number: 0008031020-2025-01075
• Device Sequence Number: 7986340
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: (01)07613327350241(11)250401(17)350331(10)K11DB6B
• 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): 09/11/2025

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: K11DB6B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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 Sex: Male