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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "while drilling into the distal screw hole, the drill passed through the screw hole, but when it was advanced further while holding the device, it broke.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to h6 health impact codes.The reported event that imn instruments - locking drill d4.2x360mm was alleged of instrument - breakage during implantation could be confirmed, since physical evaluation revealed a broken off tip.The drilling spiral of the drill returned is completely sheared off.The broken off piece was also returned.According to the appearance of the breakage surfaces, the drill broke in a (forced) brittle manner due to overload, most likely by bending stresses.The breakage may be caused by drilling under misalignment and / or contact with a hard object, which is also supported by damaged cutting edges (dents, kinks).Based on the above facts the root cause of the reported event is not related to a deficiency of the device but is rather linked to improper handling by the user.The brochure ¿instructions for cleaning, sterilization, inspection and maintenance¿ help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.Excerpts from the clinical assessment of a medical expert in a similar case of broken drill but with remaining tip part: ¿an intra-operative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved; also in the case that greater harm to the bone would be done.It is well known to an expert user that a broken part of a drill which is completely embedded in the bone normally does not cause any harm.In absence of a nickel allergy, the material used for the drill does not cause any local or systemic incompatibility.Therefore, no further surgical procedures in this special case are required.¿ 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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "while drilling into the distal screw hole, the drill passed through the screw hole, but when it was advanced further while holding the device, it broke.".

• 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: 23496236
• Report Number: 0008031020-2025-02049
• Device Sequence Number: 8992446
• Product Code: LXH
• UDI-Device Identifier: 07613327350241
• UDI-Public: (01)07613327350241(17)350630(10)K13C989
• 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): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23514236S
• Device Lot Number: KU195905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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
• Patient Age: 20 YR
• Patient Sex: Male