BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

    MDR report key: 3221039 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04210
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES USA
    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: DRILL BIT TIP BROKE OFF WHILE DRILLING INTO PATIENT'S OLECRANON DURING A PROCEDURE ON (B)(6) 2013. SURGEON STATED IT WAS BECAUSE HE DRILLED INTO SOME KWIRES ALREADY IN SITU THAT WERE PLACED THERE AS A TEMPORARY FIXATION MEASURE. THE SURGEON CHOSE NOT TO RETRIEVE THE BROKEN TOP OF THE DRILL BIT. IT WAS LEFT IN SITU IN PATIENT'S BONE. THE SURGEON DID NOT FEEL THE DRILL BIT BROKE DUE TO ANY DEFICIENCY IN THE MANUFACTURING STRENGTH OR SHARPNESS OF THE DRILL BIT, AND ATTRIBUTED IT TO THE FACT THAT HE HIT THE KWIRE WITH THE DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320566 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1