BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 6793381 · Received August 14, 2017

    Report

    Report Number
    2125289-2017-00010
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Report Date
    July 14, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GWM
    PMA / PMN Number
    K133754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 8/29/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - VISUAL EXAMINATION OF DEVICE REVEALS DEBRIS BETWEEN ARTICULATING SURFACES. (B)(6) REPAIR CENTER CONFIRMED COMPLAINT. DEVICE DISASSEMBLED CLEANED AND POLISHED. DEVICE HISTORY EVALUATION - NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND NOR WHERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH THIS LOT/WORK ORDER NUMBER. NO SERVICE HISTORY ON FILE. CONCLUSION: FAILURE ANALYSIS TO DETERMINE ROOT CAUSE CONFIRMED THE COMPLAINT EVENT. DEVICE FAILED FUNCTIONAL TEST. VISUAL EXAMINATION REVEALED DEBRIS BETWEEN PRECISION ARTICULATING SURFACES. ROOT CAUSE IS MOST LIKELY DEBRIS, (FOREIGN PARTICULATE OR ADHESIVE) AND SUBSEQUENT WEAR AND TEAR.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS ONE WISHBONE¿S ARM IS NOT MOVING. ON (B)(6) 2017 THE PROBLEM WITH THE DEVICE WAS FOUND PRIOR TO PATIENT ENTERING OR, SCHEDULED SURGERY WAS AUTOMATICALLY CANCELED. PATIENT STAYED IN THE HOSPITAL FOR THE RESCHEDULED SURGERY IN TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571242 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR GWM INTEGRA LIFESCIENCES CORPORATION OH/USA 1678283

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization