BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 4093967 · Received September 16, 2014

    Report

    Report Number
    3009450871-2014-10399
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: AS RECEIVED CONDITION: DEVICE ARRIVED AT THE SERVICE CENTER AS DISASSEMBLED COMPONENTS. THE SEPARATION OF THE SAW HEAD FROM THE HANDPIECE BY THE VISUAL INSPECTION CAN BE CONFIRMED. THE ADHESIVE CONNECTION BETWEEN OSCILLATING HEAD AND SLEEVE SHOWS NO CONTINUOUS GLUE OF THE THREADED SURFACES. UNFORTUNATELY, THIS COULD NOT BE FOUND IN NONCONFORMITY WITH SPECIFICATIONS IN THE FINAL QUALITY CONTROL. THE AFFECTED PARTS WERE MANUFACTURED IN WALDENBURG FROM (B)(4) 2013. INITIAL INVESTIGATION IDENTIFIED PROBABLE ROOT CAUSE TO BE POOR PREPARATION AND APPLICATION OF LOCTITE GLUE ON THE AREA OF THE POWER TOOL DURING THE ASSEMBLY PROCESS. ESPECIALLY ON THE AREA WHERE THE OSCILLATING HEAD IS ATTACHED TO THE POWER TOOL. FURTHERMORE, A LACK OF EFFECTIVE WORK INSTRUCTIONS CONTRIBUTED TO THIS FAILURE. IN ORDER TO ACHIEVE A PRODUCT IMPROVEMENT, AN ADJUSTMENT OF THE RE-ASSEMBLING PROCESS WERE INTRODUCED ON (B)(4) 2014. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: MOQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 IN (B)(6) AS FOLLOWS: IT WAS REPORTED WHILE PERFORMING A DEMONSTRATION ON A WOOD BLOCK, THE SAW HEAD BEGAN TO COME LOSE. THE EVENT HAPPENED IN THE AFFILIATE IN INDIA WORKSHOP. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570855 BATTERY OSCILLATOR II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1