BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT/QC/100MM

    MDR report key: 11942593 · Received June 4, 2021

    Report

    Report Number
    2939274-2021-02786
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Report Date
    May 10, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GFF
    UDI-DI
    10886982186102
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL PRO-CODES: HSZ, HWE, GFA. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTERS STATE: (B)(6). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ALL THE DRILL BITS ARE DULL, AND NEED TO BE REPLACED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT/QC/100MM. THIS REPORT IS 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837172 2.0MM DRILL BIT/QC/100MM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF WRIGHTS LANE SYNTHES USA PRODUCTS LLC 310.19 10886982186102

    Patients

    Seq Age Sex Outcome Treatment
    1