BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX

    MDR report key: 3062489 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10705
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND WAS INTACT, SHOWING SIGNS OF NORMAL USE. THE PRODUCT CONFORMED TO SPECIFICATIONS AND WAS FIT FOR ITS INTENDED USE. THEREFORE, THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION OF THE ZYGOMATIC-MAXILLARY COMPLEX (ZMC), AS THE SURGEON WAS INSERTING THE 3.5MM THREADED REDUCTION TOOL TO REDUCE THE FRACTURE, THE INSTRUMENT WAS STRIPPING THE BONE AND WOULD NOT HOLD. THE SURGEON WAS ABLE TO USE A CLAMP TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    A SATISFACTORY OUTCOME AFTER SURGERY WAS REPORTED. THERE WAS NO TIME DELAY DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163132 3.5MM THREADED REDUCTION TOOL SELF-TAPPING 78MM HEX LXH SYNTHES MONUMENT PE01032

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR