BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER

    MDR report key: 6068233 · Received October 31, 2016

    Report

    Report Number
    3032391-2016-00034
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HRX
    UDI-DI
    10888277381025
    PMA / PMN Number
    K012667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO MEDLINE RENEWAL FOR EVALUATION. OUR INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, AND WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. THE SPECIFIC CAUSE OF THE METAL SHAVINGS COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE LACK OF INFORMATION SURROUNDING THE INCIDENT, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE CUSTOMER CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED STRYKER FORMULA BARREL BUR LEFT METAL SHAVINGS IN THE PATIENT DURING A SHOULDER ARTHROSCOPY PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718873 MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER ARTHROSCOPE ACCESSORY HRX MEDLINE RENEWAL 375-951-100 314897 10888277381025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention