BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 L80/66 2FLUTE

    MDR report key: 3105053 · Received May 10, 2013

    Report

    Report Number
    1719045-2013-01424
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYNTHES MONUMENT
    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. A DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ORCHID UNIQUE MANUFACTURED THE 1.8 MM DRILL BIT/MINI QC-80 MM, PART 317.861, AND LOT NUMBER U161089. THE SUPPLIER CERTIFICATE OF COMPLIANCE, DATED NOVEMBER 8, 2012, INDICATES THE PARTS WERE MANUFACTURED TO PART 317.861, REVISION C AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4), COMPLETED NOVEMBER 12, 2012. THERE WERE NO NON CONFORMITIES OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. DUE TO AN UNKNOWN CAUSE, THE DRILL BIT APPEARED TO WOBBLE. THE MATERIAL LENGTH AND DIAMETER OF THE SHAFT WAS DETERMINED TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTRIBUTION STAFF CHECKED DRILL AND FOUND THEY WERE FLEXING ON (B)(6)2013. THE DRILL BIT WAS BENT. WHEN THEY ATTACHED THE DRILL WITH POWER TOOL, THE DRILL WAS WOBBLING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207096 DRILL BIT Ø1.8 L80/66 2FLUTE HTW SYNTHES MONUMENT U161089

    Patients

    Seq Age Sex Outcome Treatment
    1