BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP CBL DIA2 SS &CABLE SLEEV

    MDR report key: 6134700 · Received November 30, 2016

    Report

    Report Number
    3006946279-2016-00445
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    April 26, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDQ
    PMA / PMN Number
    PK982545
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF RETURNED DEVICE FOUND THE CABLE HAVE TORSION MARKS AND FIBERS BREAKAGE, THIS SHOULD BE LINKED WITH A DAMAGED TENSIONING INSTRUMENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO NON CONFORMING ASSOCIATE INSTRUMENTS. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT ¿ NI. INITIAL REPORTER SURGEON ¿ NI. THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PMA 510(K) - THIS DEVICE IS NOT DISTRIBUTED OR MANUFACTURED IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K982545.

    Description of Event or Problem · 1

    DURING A PROCEDURE, TWO CABLES FRACTURED DURING CLAMPING. IT IS NOT KNOWN IF THIS CAUSED SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786471 IMP CBL DIA2 SS &CABLE SLEEV CERCLAGE, FIXATION JDQ BIOMET FRANCE S.A.R.L. N/A 0001140665

    Patients

    Seq Age Sex Outcome Treatment
    1