MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703896
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "description of events: the fibula ancillary drill bit broke in the patient's wrist during drilling while inserting a variax wrist plate.The entire tip was recovered, and an x-ray with magnification was performed to ensure that no pieces remained in the patient's bone.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "description of events: the fibula ancillary drill bit broke in the patient's wrist during drilling while inserting a variax wrist plate.The entire tip was recovered, and an x-ray with magnification was performed to ensure that no pieces remained in the patient's bone.".
Additional Manufacturer Narrative
Correction: please refer to section d2a, d2b and g1 (manufacturing site for devices).The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned drill bit could be confirmed based on the catalog number and the lot number marked.The returned drill bit is broken in two parts, close to the tip.The detached fragment has not been returned.The surface of the breakage give evidence of a sudden brittle fracture, due to excessive bending and/or torsional load.Dimensional and material integrity inspections have confirmed that the has been manufactured according to specification.Based on investigation, the root cause was attributed to user related issue.The event was caused by excessive load applied to the instrument.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.If more information is provided, the case will be reassessed.

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23154776
• Report Number: 0008031020-2025-01644
• Device Sequence Number: 5290695
• Product Code: LXH
• UDI-Device Identifier: 07613327070064
• UDI-Public: 07613327070064
• 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): 12/15/2025

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: 703896
• Device Lot Number: AP09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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 Sex: Unknown