BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3103148 · Received May 9, 2013

    Report

    Report Number
    1719045-2013-01421
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ORCHID UNIQUE MANUFACTURED THE 2.5MM DRILL BIT/QC/GOLD/110MM, P/N 310.25, AND LOT NUMBER U168432. THE SUPPLIER'S CERTIFICATE OF COMPLIANCE (DATED JANUARY 28, 2013 FOR THREE SEPARATE RECEIPTS OF THIS LOT) INDICATES THE PARTS WERE MANUFACTURED TO P/N 310.25, REVISION "M" AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER NS061004, REVISION "A" (COMPLETED 2/7/13, 2/11/13, AND 2/20/13). THERE WERE NO MRR'S, NCR'S, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE THREE RECEIPTS OF THIS LOT WERE RELEASED 2/8/13, 2/12/13, AND 2/21/13.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT: DURING A RIGHT TIBIAL PLATEAU PROCEDURE ON (B)(6) 2013, A DRILL BIT BROKE. THE EVENT OCCURRED DURING MEDIAL AND LATERAL PLATING, INVOLVING MULTIPLE SCREWS IN THE METAPHYSEAL AREA; AND WHERE THE DRILL BIT DEFLECTED OFF ONE OF THE SCREWS AND BROKE. IT WAS ALSO REPORTED THE FRAGMENT WAS REMOVED, AND ANOTHER DRILL BIT WAS UTILIZED TO COMPLETE THE PROCEDURE WITH MINIMAL DELAY. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203799 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT U168432

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR