BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP F/CORTSCR Ø3.5 L110/50

    MDR report key: 2921700 · Received January 18, 2013

    Report

    Report Number
    2520274-2013-00428
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    March 30, 2009
    Report Date
    April 21, 2009
    Manufacturer
    SYNTHES
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) COMPLAINT HANDLING UNIT REPORTED THE TIP OF A DRILL BIT BROKE OFF FOR THE TREATMENT OF A DISTAL HUMERAL. TWO LOCKING COMPRESSION PLATES WERE USED. THE FIRST PLATE WAS TEMPORARILY FIXED WITH A CORTEX SCREW. THE CORTEX SCREW WAS SELECTED FOR THE SECOND SCREW. DURING TAPPING, THE SURGEON FELT THE BONE HARDNESS AND TOOK THE TROUBLE TO TAP. THE TIP OF THE TAP DID NOT GO THROUGH THE OPPOSITE DRILLED HOLE OF BONE AND THE TIP CONTACTED WITH THE INNER CORTIAL BONE. AS A RESULT, THE DRILL BIT BROKE. THE SURGEON DECIDED TO LEAVE THE BIT IN THE PATIENT DUE TO THE DIFFICULTY IN REMOVING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27979 TAP F/CORTSCR Ø3.5 L110/50 TAP F/CORTSCR Ø3.5 L110/50 HWX SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1