BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1 L50/35

    MDR report key: 2924492 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00160
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 26, 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ORCHID UNIQUE MANUFACTURED THE 1.0MM DRILL BIT MINI QC 50MM, PART 316.396, LOT U145568. THE LOTS WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND. THE LOT PASSED SYNTHES INSPECTION SHEET. THE BROKEN SURFACE IS HOMOGENOUS, WHAT INDICATES MATERIAL CONFORMITY AS WELL. THE DRILL BIT IS BROKEN DUE TO MECHANICAL OVERLOADING DURING USE. WE STRONGLY HAVE TO ASSUME THAT THE TIP OF THE DRILL BITS CAME IN STRONG CONTACT WITH THE K WIRE AND BLOCKED WHAT LEAD TO THE BREAKAGE FINALLY. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A RADIAL HEAD FRACTURE PROCEDURE USING HCS AND MHS PLATE, TWO DRILL BITS WERE BROKEN. THE SURGEON REMOVED EVERY VISIBLE BROKEN PIECE FROM THE SURGICAL FIELD WITH DIFFICULTY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DRILL BIT. THE SURGEON REPORTEDLY DID FEEL THAT HE PUT EXTRA LOAD ON THE GUIDE WIRE. IT WAS REPORTED THE PATIENT HAD A GOOD BONE QUALITY. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29990 DRILL BIT Ø1 L50/35 DRILL BIT HTW SYNTHES MONUMENT U145568

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR DRILL BIT