BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING

    MDR report key: 3080869 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10537
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF AN IMF SCREW FOR AN ORIF OF THE MANDIBLE, THE SCREWDRIVER TINES BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED. SURGEON USED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180990 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING HXX SYNTHES BRANDYWINE 5219467

    Patients

    Seq Age Sex Outcome Treatment
    1