BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.8 W/STOP

    MDR report key: 3101746 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02447
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, A SURGEON WAS USING A DRILL GUIDE AND DRILL BIT WITH STOP WHEN THE SURGEON'S GLOVE BECAME ENTANGLED WITH THE DRILL GUIDE AND TORE. IT WAS REPORTED THAT IT APPEARED THAT THE SURGEON'S GLOVE WAS UNKNOWINGLY COVERING ONE OF THE PROXIMAL HOLES IN THE DRILL GUIDE AND ROTATION OF THE DRILL BIT THROUGH THE GUIDE HAD LIKELY SNAGGED THE GLOVE. THE DRILL GUIDE AND DRILL BIT WERE SWAPPED AND NO INJURY TO THE SURGEON OR PATIENT WAS REPORTED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202750 DRILL BIT Ø2.8 W/STOP FZX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1