BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3143443 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03057
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K962913
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON DECIDED TO USE HEADLESS COMPRESSION SCREWS (HCS) FOR THE OPERATION OF A SCAPHOID FRACTURE ON (B)(6) 2013. WHILE USING A CANNULATED DRILL BIT TO DRILL OVER THE 1.1MM GUIDE WIRE, THE DRILL BIT BROKE AND REMAINED IN THE BONE. IT WAS A DORSAL APPROACH, SO THE SURGEON APPROACHED FROM THE PALMAR SIDE AND REMOVED ALL FRAGMENTS OF THE BROKEN DRILL BIT. REPORTEDLY, THE GUIDE WIRE BOWED AND INTERFERED WITH THE DRILL AND PUSHED IT, SO THE DRILL BIT WAS BROKEN UNDER THE INTERFERENCE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245310 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1