BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 L85/60 2FLUTE

    MDR report key: 3004007 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-00902
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 14, 2013
    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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE COMPLAINED DRILL BIT HAS SHOWN THAT IT BROKE DUE TO TEMPORARY OVERLOAD. THE CAUSE CAN NOT BE IDENTIFIED CLEARLY. WE CAN ONLY ASSUME THAT THE MAXIMUM LOAD WAS EXCEEDED WITH AN UNINTENDED BENDING MOMENT OR CONTACT WITH METAL, WHICH CAUSED THE BREAK. NO DEVIATION WITH THE MANUFACTURING AND MATERIAL DOCUMENT WAS FOUND. NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE DRILL BIT BROKE INTRA OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107492 DRILL BIT Ø1.5 L85/60 2FLUTE HTW SYNTHES GMBH 1007410

    Patients

    Seq Age Sex Outcome Treatment
    1