BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    2.2MM LINDEMANN DRILL BIT

    MDR report key: 17399004 · Received July 26, 2023

    Report

    Report Number
    3015967359-2023-01631
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    June 30, 2023
    Report Date
    October 25, 2023
    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. SUPPLEMENTAL RATIONALE CORRECTED DATA: H6, H10 6 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED. 5 DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    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 (B)(4) EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS (B)(4) DEVICES WERE NOT AVAILABLE FOR EVALUATION. (B)(4) DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION (B)(4) DEVICES WERE LABELED FOR SINGLE-USE. (B)(4) DEVICES WERE NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 3 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. (B)(4) EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. (B)(4) EVENTS HAD INSUFFICIENT INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630509 2.2MM LINDEMANN DRILL BIT BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VMSR 04546540030597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown