BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER

    MDR report key: 6088142 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00016
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    April 5, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HRX
    UDI-DI
    10888277354692
    PMA / PMN Number
    K012667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT AND INVESTIGATION. HOWEVER, UNUSED INVENTORY OF SIMILAR DEVICES WAS RETURNED TO MEDLINE RENEWAL AS PART OF THE COMPLAINT INVESTIGATION. REVIEW OF THE UNUSED INVENTORY CONFIRMED THE POSSIBILITY OF THE REPORTED DEVICE FAILURE. MEDLINE RENEWAL PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS AND DETERMINED THAT THIS INCIDENT MET THE CRITERIA FOR MDR REPORTING BUT WAS NOT FILED WITHIN THE REQUIRED 30 DAY TIMEFRAME. ALTHOUGH NO PATIENT HARM WAS REPORTED, INTERVENTION MAY HAVE BEEN REQUIRED TO COMPLETE THE PROCEDURE, THEREFORE, MEDLINE RENEWAL IS RETROSPECTIVELY FILING THIS MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REPROCESSED DYONICS PLATINUM ARTHROSCOPIC SHAVER SNAPPED APART IN THE KNEE DURING USE. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737605 MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER ARTHROSCOPIC ACCESSORY HRX MEDLINE RENEWAL 72203013 UNKNOWN 10888277354692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention