BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNGD PS BOX CHISEL

    MDR report key: 6595843 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03464
    Event Type
    Malfunction
    Date Received
    May 26, 2017
    Date of Event
    April 27, 2017
    Report Date
    October 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: PRODUCT CODE. PRODUCT CODE: FZO. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. PER THE INSTRUCTIONS FOR USE, UNDER CARE AND HANDLING OF INSTRUMENTS, IT STATES SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FROM PROLONGED USE, AND THROUGH MISUSE OR ROUGH HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE. IT ALSO STATES INSPECT THE INSTRUMENTS AND INSTRUMENT CASES FOR DAMAGE WHEN PURCHASED AND AFTER EACH USE AND CLEANING. INCOMPLETELY CLEANED INSTRUMENTS SHOULD BE RE-CLEANED, AND THOSE THAT NEED REPAIR SET ASIDE FOR REPAIR SERVICE OR RETURN TO BIOMET. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. AS THE PRODUCT HAS BEEN IN THE FIELD FOR APPROXIMATELY 12 YEARS, THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE WEAR AND TEAR FROM USE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY THE BOX CHISEL BROKE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376662 VNGD PS BOX CHISEL CHISEL, SURGICAL JWH BIOMET ORTHOPEDICS 350860

    Patients

    Seq Age Sex Outcome Treatment
    1