BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4/2.7MM VA-LCP BENDING PLIER

    MDR report key: 4911954 · Received July 14, 2015

    Report

    Report Number
    9680938-2015-10061
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    May 8, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. DEVICE HISTORY REVIEW: MANUFACTURING DATE: SEPTEMBER 6, 2010. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIALS, WHICH WERE DELIVERED AS LOT KR83729 FOR HANDLES AND LOTS 331270, 83508, AND 302203 FOR JAWS, ARE CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 55.5 HRC FOR 1.4112 AND 47.8-48.5 HRC FOR 1.4021. BOTH WERE FOUND TO BE GOOD. A NON-CONFORMANCE REPORT ABOUT SCRATCHES, GROOVES, AND BLACK STAINS IN THE SURFACE OF THE JAWS WAS CREATED. THIS NONCONFORMITY HAS NO BEARING TO THIS COMPLAINT CONDITION. MANUFACTURING EVALUATION: THE LOWER JAW OF A PAIR OF BENDING PLIERS HAS SHEARED OFF AT THE TIPS. ONLY THE FRONT CLOVER PIN WAS BROKEN OFF. AN INSPECTION OF THE FRONT PIN WAS NOT POSSIBLE AS IT WAS NOT RETURNED; HOWEVER, AS BOTH PINS ARE MACHINED AT THE SAME TIME, IT CAN BE CONCLUDED THAT BOTH ARE DIMENSIONALLY THE SAME. AN INSPECTION OF THE SECOND PIN, IN BOTH WIDTHS, REVEALS THAT THE PINS ARE DIMENSIONALLY CONFORMING. A HARDNESS TEST WAS CARRIED OUT AND REVEALED THAT THE HARDNESS IS APPROXIMATELY 1 HRC OVER THE MAXIMUM LIMIT OF 56 HRC AT 56.8-57.2 HRC. THE HARDNESS AT THE TIME OF MANUFACTURING WAS MEASURED 55.5 HRC. IN THE MEANTIME, THE DEVICE HAS AGED APPROXIMATELY FIVE (5) YEARS AND IT CANNOT BE EXACTLY DETERMINED IF THIS HAS AN EFFECT TO THE HARDNESS. BASED ON EXPERIENCE, JUDGMENT, AND THE AGE OF THE INSTRUMENT, IT WAS CONCLUDED THAT THE DEVICE BROKE DUE TO MISUSE OR TOO MUCH FORCE WAS APPLIED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PAIR OF BENDING PLIERS WAS DISCOVERED TO BE BROKEN DURING STERILE PROCESSING. UPON FURTHER INVESTIGATION, AFTER RECEIPT OF THE PRODUCT BY THE MANUFACTURER, IT WAS DETERMINED THAT THE LOWER JAW WAS SHEARED OFF AT THE TIPS. THE FRONT CLOVER PIN WAS ALSO BROKEN OFF. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457435 2.4/2.7MM VA-LCP BENDING PLIER PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN T948693

    Patients

    Seq Age Sex Outcome Treatment
    1