BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 L45/33 2FLUTE

    MDR report key: 2890988 · Received December 31, 2012

    Report

    Report Number
    8030965-2012-01718
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MEASURABLE DIMENSIONS WERE CHECKED AND WERE FOUND TO BE IN SPECIFICATION. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. IT IS POSSIBLE THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY FOR EXAMPLE; TOO HIGH DRILL SPEED, HARD BONE OR POSSIBLE MOVEMENT IN A SLANTING POSITION. WE ARE AWARE THAT THESE ARE VERY DELICATE DRILL BITS WHICH REQUIRE EXTRA CAUTION DURING USE. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A DRILL BIT. IT WAS REPORTED THAT THE DRILL BROKE DURING THE DRILLING, LEAVING THE TIP OF THE DRILL BIT IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT Ø1.1 L45/33 2FLUTE DRILL BIT HTW SYNTHES GMBH F-13444

    Patients

    Seq Age Sex Outcome Treatment
    1