BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0

    MDR report key: 2921318 · Received January 17, 2013

    Report

    Report Number
    1719045-2013-00145
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    July 29, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, THE DRILL BIT TO PREPARE FOR THE SCREW BROKE IN THE HUMERUS OF THE PATIENT. THE BROKEN PIECE REMAINS IN SITU. REPORTEDLY THERE WERE NO CLINICAL CONSEQUENCES. THERE WAS ANOTHER DEVICE AVAILABLE FOR USE. THE DRILL BIT WAS DISCARDED OF BY THE ACCOUNT AND SUBSEQUENTLY THE LOT NUMBER IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26589 DRILL BIT Ø3.2 CALIBR L340 3FLUTE F/03.0 DRILL BIT HTW SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1