BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM CANNULATED DRILL BIT/QC 170MM

    MDR report key: 2872388 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01358
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS AND RAW MATERIAL WAS REVIEWED AND CONFORMED TO ALL REQUIREMENTS. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT PE00848 REVEALED THE 3.2 MM CANNULATED DRILL BIT WAS MANUFACTURED BY PRECISION EDGE SURGICAL. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE DESIGN WAS REVIEWED, IS ACCEPTABLE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. DUE TO THE LOW OCCURRENCE RATE OF COMPLAINTS, THE SUITABLE DESIGN SINCE 1999, AND THERE IS VISUAL EVIDENCE OF AN OFF AXIS LOAD APPLIED TO THE RETURNED DEVICE CAUSING BREAKAGE.

    Description of Event or Problem · 1

    DURING AN ORIF OF THE LEFT FOOT AT THE FIFTH METATARSAL FRACTURE PROCEDURE, TOWARDS THE END OF THE PROCEDURE THE SURGEON WAS RETRACTING THE DRILL AND THE DRILL BIT BROKE INTO TWO PIECES. THE TWO BROKEN PIECES OF THE DRILL BIT DID FALL INTO THE PATIENT BUT WERE RETRIEVED. THE PROCEDURE WAS PROLONGED A FEW MINUTES BECAUSE OF THIS INCIDENT BUT THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.2MM CANNULATED DRILL BIT/QC 170MM CANNULATED DRILL BIT HWC SYNTHES MONUMENT PE00848

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR