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	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "it was reported that while the surgeon was drilling a distal screw hole in the gamma nail, the 4.2 mm drill bit broke off inside the hole.The surgeon was unable to retrieve the broken drill bit piece and chose to leave it inside the gamma nail hole.An x-ray was taken and the surgeon stated that the broken drill bit piece are quite stacked and would not be able to migrate.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9 (product available to stryker).The reported event could not be confirmed since the affected device was not returned, and no evidence was provided for evaluation.That batch record could not be reviewed because the affected device was not returned and the lot number communicated was incorrect.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available to confirm and determine the exact root cause of the issue.However, it must be noted that the reported drill belongs to the t2 alpha family while as per the event description and the drill was used for the gamma3 nail implantation, which is an unapproved use.The ifu clearly warns the user the following: only use an instrument for its intended purpose.Improper use of instruments may lead to loss in function or usage.If the device is returned or in any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "it was reported that while the surgeon was drilling a distal screw hole in the gamma nail, the 4.2 mm drill bit broke off inside the hole.The surgeon was unable to retrieve the broken drill bit piece and chose to leave it inside the gamma nail hole.An x-ray was taken and the surgeon stated that the broken drill bit piece are quite stacked and would not be able to migrate.".

• 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: 23917958
• Report Number: 0008031020-2025-02307
• Device Sequence Number: 9194209
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: 07613327350241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/03/2026
• 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