BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRS - GLENOID RESURFACING SYSTEM

    MDR report key: 6431184 · Received March 24, 2017

    Report

    Report Number
    3004154314-2017-00004
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 20, 2017
    Report Date
    March 1, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWS
    PMA / PMN Number
    K091196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO HARM TO THE PATIENT OR TO THE USER AS A RESULT OF THE REPORTED ISSUE. THE EXACT REASON FOR THE FAILURE OF PEG DRILL IS UNKNOWN SINCE THE DEVICE WAS DISCARDED AFTER SURGERY AND NOT AVAILABLE FOR EVALUATION. AS A PART OF THE INVESTIGATION, THE MANUFACTURING RECORDS (INCOMING AND FINAL INSPECTION) WERE REVIEWED AND NO ISSUES NOTED. REVIEW OF PEG DRILL LOT (INCOMING) SHOWED COMPLIANCE TO FUNCTIONAL SPECIFICATIONS. POOR EXPOSURE OR ACCESS TO THE OPERATING SITE MAY HAVE RESULTED IN INTERFERENCE OF THE DEVICE WITH OTHER SURGICAL INSTRUMENTS. THE SURGICAL HISTORY OF THE LOT HAS BEEN REVIEWED AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE COMPLAINT IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEG DRILL FROM A GLENOID REAMER KIT WAS BROKEN DURING A SHOULDER SURGERY. THE SURGEON USED A PEG DRILL FROM ANOTHER GLENOID REAMER KIT READILY AVAILABLE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215784 GRS - GLENOID RESURFACING SYSTEM SHOULDER JOINT PROSTHESIS, GLENOID COMPONENT KWS ARTHROSURFACE, INC. G000-0100 75IF1504

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other