BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/EXPERT TN+FN

    MDR report key: 3173973 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03417
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 28, 2012
    Report Date
    May 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE VISUAL INSPECTION AND EVALUATION HAS SHOWN THAT THE NOSE ON THE HANDLE IS FLATTENED ONLY AND NOT BROKEN. NO ABNORMAL FINDINGS WERE IDENTIFIED AND IT IS CONCLUDED THAT NORMAL WEAR AND TEAR AND TORSIONAL FORCES CAUSED THIS DEFORMATION. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE INSTRUMENT WAS MANUFACTURED TO SPECIFICATIONS AND IT WAS CONCLUDED THAT NORMAL WEAR AND TEAR IN COMBINATION WITH TORSIONAL FORCES CAUSED THIS DEFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NOSE ON THE INSERTION HANDLE BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274305 INSERT-HANDLE F/EXPERT TN+FN LXH SYNTHES GMBH 1676601

    Patients

    Seq Age Sex Outcome Treatment
    1