BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 L85/60 2FLUTE

    MDR report key: 3414303 · Received October 16, 2013

    Report

    Report Number
    2520274-2013-06826
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE USED IN A VETERINARY CASE. NO PATIENT INFORMATION WILL BE REPORTED. ADDITIONAL CODE: HSZ. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A VETERINARY PROCEDURE ON A SMALL CANINE FOUR DRILL BITS BROKE. ALL FOUR DRILL BITS BROKE AT THE SAME LEVEL. THIS REPORT IS 4 OF 4 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531205 DRILL BIT Ø1.5 L85/60 2FLUTE HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1