BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER WITH UNIVERSAL CHUCK

    MDR report key: 3031811 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10676
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    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 DATE, 4/6/2004. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE NAILING OF A RIGHT FEMUR FIXATION, SURGEON TIGHTENED THE INSERTER ONTO NAIL. WHEN THE SURGEON ATTEMPTED TO LOOSEN IT, THE HANDLE CAME OFF.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134458 INSERTER WITH UNIVERSAL CHUCK LXH SYNTHES GMBH 8001106

    Patients

    Seq Age Sex Outcome Treatment
    1