BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES

    MDR report key: 6390210 · Received March 8, 2017

    Report

    Report Number
    9680938-2017-10037
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 14, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    UDI-DI
    10887587041032
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE: NOV 11, 2005. THE REVIEW SHOWED THAT THERE WERE THREE (3) DIFFERENT MANUFACTURING LOTS UNDER A7OA45: BA# 903322, BA# 903324, AND BA# 903316. THE REVIEW OF ALL THREE LOTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. A VISUAL INSPECTION, DRAWING REVIEW AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE COMBINATION BENDING/CUTTING PLIERS WERE CONFIRMED TO HAVE A BROKEN LEAF SPRING. THE SPRING BROKE WHERE IT IS SCREWED INTO THE HANDLE. THE DEVICE SHOWS NORMAL SURFACE WEAR FROM OVER 11 YEARS OF USE. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE DEVICE IS OVER 11 YEARS OLD AND THE LEAF SPRING LIKELY WEAKENED DUE TO NUMEROUS USE AND STERILIZATION CYCLES. DEVICE WAS 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 DURING A MID-FACE ORBITAL FLOOR BLOWOUT PROCEDURE ON (B)(6) 2017, WHILE THE SURGEON WAS BENDING THE PLATE ON THE BACK-TABLE, THE TENSION SPRING BROKE NEAR THE MAIN FRAME OF THE COMBINATION BENDING/CUTTING PLIERS AND FELL OUT. THE SURGEON EASILY RETRIEVED THE SPRING. SINCE THIS EVENT OCCURRED AT THE BACK TABLE, THE SPRING DID NOT FALL INTO THE PATIENT¿S WOUND. THE SURGEON FINISHED THE PROCEDURE WITH A READILY AVAILABLE BACK-UP DEVICE. THERE WAS NO SURGICAL TIME DELAY OR HARM TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PLATE - PART# - UNKNOWN, LOT# - UNKNOWN, QUANTITY# - 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170662 COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN A70A45 10887587041032

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE UNKNOWN PLATE, QUANTITY 1