BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3143465 · Received June 3, 2013

    Report

    Report Number
    2520274-2013-03059
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DESCRIPTION CONTINUED: TWO NEW SYNTHES PLATES WERE IMPLANTED. DURING DRILLING, THE DRILL BIT BROKE. ALL PIECES OF THE BIT WERE RETRIEVED. SURGEON USED ANOTHER DRILL BIT, AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 3 OF 3 FOR (B)(4). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON TREATED THE PATIENT WITH EX-FIX (EXTERNAL FRACTURE FIXATION) TO THE ELBOW FOR TEMPORARY FIXATION UNTIL THE SWELLING SUBSIDED. ON (B)(6) 2013, THE PATIENT RETURNED TO THE OR FOR REMOVAL OF EX-FIX AND IMPLANTATION OF 2 VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) DISTAL HUMERUS PLATES. ON AN UNKNOWN DATE POST-OPERATIVELY, THE PATIENT FELL. X-RAYS SHOWED THE 9-HOLE MEDIAL PLATE WAS BROKEN AT THE PROXIMAL 1/3 SECTION OF THE PLATE. SINCE THE FRACTURE WAS STILL STABLE, SURGICAL INTERVENTION WAS NOT INDICATED. APPROXIMATELY ONE WEEK LATER ON AN UNKNOWN DATE, THE PATIENT FELL AGAIN, AND BROKE THE SECOND VA-LCP PLATE. ON (B)(6) 2013, THE PATIENT RETURNED TO THE OR FOR REMOVAL OF THE TWO BROKEN PLATES, AND 14 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243649 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES USA 0163999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention