BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM DRILL BIT/QC/110MM

    MDR report key: 2924452 · Received January 22, 2013

    Report

    Report Number
    3003506883-2013-00014
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. (B)(4) REPORTED THE CATALOG #, LOT #, AND SERIAL #; THESE ARE INVALID SYNTHES CATALOG #, LOT #, AND SERIAL #. BASED UPON THE REPORTED SERIAL NUMBER OF (B)(4), IT WAS DETERMINED THAT THE SERIAL NUMBER IS A VALID LOT NUMBER FOR CATALOG #310.35.

    Description of Event or Problem · 1

    (B)(4) WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30132 3.5MM DRILL BIT/QC/110MM HTW SYNTHES ELMIRA 5610955

    Patients

    Seq Age Sex Outcome Treatment
    1