BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BENDING PLIERS

    MDR report key: 5074120 · Received September 14, 2015

    Report

    Report Number
    9680938-2015-10090
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. DEVICE HISTORY REVIEW: MANUFACTURING DATE: MARCH 21, 1995. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE RECORDS COULD NOT BE IDENTIFIED DUE TO THE AGE OF THE INSTRUMENT. PRODUCT INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PLIER JAW TIPS ARE DAMAGED. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS PORTIONS OF THE CARBIDE INSERTS ARE MISSING ON BOTH JAWS. A DEFINITIVE ROOT CASE WAS UNABLE TO BE IDENTIFIED; THE FAILURE IS CONSISTENT WITH WEAR AND TEAR OVER 20+ YEARS IN THE FIELD (MANUFACTURED IN MARCH, 1995). THE COMPLAINT IS CONFIRMED. THE UNIVERSAL BENDING PLIERS ARE UTILIZED IN MULTIPLE SYSTEMS (2.7MM VA LOCKING CALCANEAL PLATE, 3.5MM VA LCP MEDIAL COLUMN FUSION PLATE, MODULAR HAND, STERNAL FIXATION, ETC.) THEY ARE UTILIZED TO CONTOUR PLATES PRIOR TO IMPLANTATION TO BETTER MATCH A PATIENT¿S ANATOMY. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE CARBIDE INSERTS ON BOTH TIPS ARE MISSING SECTIONS. THE INSTRUMENT WAS MANUFACTURED IN MARCH, 1995 AND HAD BEEN IN THE FIELD FOR OVER 20 YEARS. THIS FAILURE CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE/ROUGH HANDLING REPEATEDLY OVER THE LIFE OF THE DEVICE. A RELEVANT DRAWING FOR THE RETURNED INSTRUMENT WAS REVIEWED. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE RECORDS COULD NOT BE IDENTIFIED DUE TO THE AGE OF THE INSTRUMENT. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS ORIGINALLY REPORTED THAT A PAIR OF PLIER JAW TIPS WAS DAMAGED. UPON EVALUATION AT THE COMPLAINT HANDLING UNIT, WHICH WAS COMPLETED ON (B)(6) 2015, THE DAMAGE WAS FURTHER CLARIFIED TO INCLUDE BROKEN TIP AND MISSING FRAGMENTS. NO PATIENT OR SURGICAL INVOLVEMENT WAS REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607569 UNIVERSAL BENDING PLIERS PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN A7EA21

    Patients

    Seq Age Sex Outcome Treatment
    1