BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 6793218 · Received August 14, 2017

    Report

    Report Number
    2125289-2017-00009
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Report Date
    July 14, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 8/7/17 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - DURING INVESTIGATION THE FOLLOWING WAS OBSERVED: EVALUATION VERIFIED CUSTOMER INFORMATION AS VALID. THE PRESSURE OF THE LOCKING MECHANISM IS TOO LOW. SMALL PARTS ARE WORN. MARKED WITH INDIVIDUAL ITEM NUMBER. 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 IDENTIFY ROOT CAUSE CONFIRMED COMPLAINT EVENT. UPON INCOMING ANALYSIS DEVICE FAILED FUNCTIONAL TESTING, LOOSE CLAMPING. (B)(4) SERVICE CENTER IDENTIFIED WORN PARTS AND REPLACED THEM. ROOT CAUSE MOST LIKELY WEAR AND TEAR.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO SMALL LOCKING FORCE IN THE LOCKING MECHANISM. ARMS ARE MOVING UNDER TISSUES PRESSURE OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572201 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1