BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 17749812 · Received September 14, 2023

    Report

    Report Number
    3004608878-2023-00170
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 23, 2023
    Report Date
    October 4, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STANDARD WISHBONE ASSEMBLY (4020) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: UPON INSPECTION OF THE RETURNED UNIT, IT WAS DISCOVERED THAT THE ARMS INDEED MOVED IN THE LOCKED POSITION. PREVENTATIVE MAINTENANCE AND REPLACEMENT OF WORN PARTS WERE REQUIRED. ROOT CAUSE ANALYSIS: COMPLAINT CONFIRMED. BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE WAS MOST LIKELY DUE TO INSUFFICIENT ROUTINE PREVENTIVE MAINTENANCE. BASED ON THIS EVALUATION, ROOT CAUSE DETERMINATION, AND RISK ASSESSMENT, NO FURTHER ACTION OR INVESTIGATION IS PLANNED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARM OF STANDARD WISHBONE ASSEMBLY (4020) WAS NOT HOLDING PROPERLY; IT WAS ROTATING. ONCE THE WISHBONE FRAME WAS LOCKED, IT IS MEANT TO STAY LOCKED; HOWEVER, THE WISHBONE FRAME MOVED. A 30-MINUTE DELAY IN SURGERY OCCURRED AS THE SURGEON HAD TO WAIT FOR ANOTHER RETRACTOR. A NEW RETRACTOR FRAME WAS OPENED, AND THE SURGEON TOLD STAFF THAT THE REPLACEMENT RETRACTOR WAS ALSO MOVING; HOWEVER, THE SURGEON USED THAT FRAME BECAUSE THERE WAS NO REPLACEMENT AVAILABLE. IT WAS INDICATED THAT THE REPLACEMENT RETRACTOR DID NOT CONTRIBUTE TO A DELAY IN SURGERY. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362427 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR GAD INTEGRA LIFESCIENCES CORPORATION OH/USA M42694

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown