BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    2.2MM LINDEMANN DRILL BIT

    MDR report key: 23399803 · Received October 28, 2025

    Report

    Report Number
    3015967359-2025-99417
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Report Date
    January 27, 2026
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    GFF
    UDI-DI
    04546540030597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS. 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVALUATION FINDINGS (RESULTS/COMPONENTS). 1 DEVICE: RESULTS PENDING COMPLETION OF INVESTIGATION / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PRODUCT DISPOSITION. 1 DEVICE: PRODUCT DISPOSITION IS NOT YET DETERMINED. ADDITIONAL INFORMATION. 1 DEVICE WAS LABELED FOR SINGLE-USE. 1 DEVICE WAS NOT REPROCESSED OR REUSED.

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. MFR REPORT # 3015967359-2025-99417. SUPPLEMENTAL RATIONALE CORRECTED DATA: B5, H6, H11 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED. EVALUATION FINDINGS (RESULTS/COMPONENTS) 1 DEVICE: FRACTURE PROBLEM / PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE PRODUCT DISPOSITION 1 DEVICE: ARCHIVED BY STRYKER.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    NO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427690 2.2MM LINDEMANN DRILL BIT BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 04546540030597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown