BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-BEND-PLIERS L165

    MDR report key: 3191927 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04149
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    October 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. OUR INVESTIGATIONS HAVE SHOWN THAT ONE PRONG OF THE COMPLAINED PLIERS IS INDEED BROKEN OFF. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. 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 APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. IT IS NOTED THAT THE ITEM WAS SOLD IN 2008. THEREFORE, WE DO SUPPOSE THAT THE BREAKAGE RESULTED DUE TO NORMAL WEAR AND TEAR OVER THE YEARS. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LED TO THIS DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIVERSAL BENDING PLIERS BROKE DURING THE BENDING OF A PLATE. 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
    292901 UNIV-BEND-PLIERS L165 HTC SYNTHES GMBH A7RA42

    Patients

    Seq Age Sex Outcome Treatment
    1