BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRIMPER F/TRANSV-ONNECTORS

    MDR report key: 3181777 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03644
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2012
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 EVENT WAS CONFIRMED. OUR INVESTIGATION HAVE SHOWN THAT ONE TIP OF THE FORCEPS IS INDEED BROKEN AND HAS SNAPPED OFF. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. WE DO SUPPOSE THOUGH THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN OR POSSIBLE MISALIGNMENT DURING THE LOCKING OF THE TRANS CONNECTOR MAY HAVE CAUSE THIS DAMAGE. THE BROKEN SURFACE ITSELF IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. 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. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN. NEVERTHELESS, AS WE ARE NOT ABLE TO REPAIR THIS INSTRUMENT, WE ARE PLEASED TO REPLACE IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BROKEN AND THE BROKEN PART HAS BEEN DISPOSED OF. 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
    281711 CRIMPER F/TRANSV-ONNECTORS HWN SYNTHES GMBH T941524

    Patients

    Seq Age Sex Outcome Treatment
    1