BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

    MDR report key: 2963107 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00474
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    August 7, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES GMBH
    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 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 AN EVENT ON (B)(6) 2012 THE FUNNEL SHAPED VA LCP DRILL SLEEVE GUIDE FOR THE 2.7MM LOCKING SCREWS GAVE LITTLE GUIDANCE FOR THE 2.0MM DRILL. REPORTEDLY DRILL BREAKAGE OCCURRED. NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67417 DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 DRILL BIT HTW SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1