BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE

    MDR report key: 3316762 · Received August 29, 2013

    Report

    Report Number
    8030965-2013-04729
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    July 23, 2013
    Report Date
    August 2, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED; 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COORDINATED BY (B)(4). REPORT RECEIVED INDICATES THE TIP OF INSTRUMENT IS BROKEN OFF. THE DRILL BIT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED AND NO ABNORMAL FINDINGS WERE IDENTIFIED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES (THE BROKEN PART WAS NOT RETURNED). THERE MAY HAVE BEEN A MECHANICAL OVERLOAD OR THE DRILL BIT MAY NOT HAVE BEEN ALIGNED AT THE CORRECT ANGLE IN THE HOLE OF THE NAIL, WHICH ALSO MAY HAVE LED TO THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DRILL BIT BROKE INSIDE THE NAIL, WHEN THE SURGEON WAS DRILLING THE DISTAL HOLE OF THE NAIL. THE DRILL TIP WAS WITHIN THE DISTAL HOLE OF THE NAIL TAKING THE PLACE OF THE SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426922 DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE HTW SYNTHES GMBH 2702441

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR