BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD XR2 METAL-FREE CONVERSION ADAPTOR-POOL UNIT

    MDR report key: 6134586 · Received November 30, 2016

    Report

    Report Number
    3004608878-2016-00330
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/12/2017. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: ENGINEERING AND REPAIRS WERE NOT ABLE TO CONFIRM THE CUSTOMER COMPLAINT. DURING FUNCTIONAL INSPECTION, THE METAL FREE ARM¿S CARRIER (439A1027) DID NOT GET LOOSE AND IT PERFORMED WELL. THIS WAS TRIED MULTIPLE TIMES. THIS DEVICE WAS MANUFACTURED ON APRIL 14TH, 2014 AND A REVIEW OF THE DHR CONTAINING LOT CODE 144 AND SERIAL NUMBER (B)(4) SHOWED THAT THE FOLLOWING LOT PASSED THE REQUIRED INSPECTION POINTS WITHOUT MRRS, REWORKS OR VARIANCES. THERE IS NO SERVICE HISTORY FOR THIS DEVICE. A TWO YEAR LOOKBACK IN TRACKWISE FOR THIS REPORTED FAILURE AND OR RELATED TO "METAL FREE RATCHET PIN AND STOP WHEEL BECAME LOOSE" FOR THIS PRODUCT ID SHOWS THAT 2 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: ENGINEERING AND REPAIRS WERE NOT ABLE TO VERIFY THE CUSTOMER COMPLAINT; THEREFORE, NO ROOT CAUSE CAN BE ATTRIBUTED AT THIS TIME. THIS METAL FREE ARM WAS MANUFACTURED IN 2014 AND WAS NOT SENT IN FOR REPAIRS/MAINTENANCE SINCE. THIS IS AN ISOLATED INCIDENT AND WILL BE MONITORED FOR TRENDING.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PATIENT, SAME SURGERY, SAME PRODUCT PROBLEM, DIFFERENT PRODUCT ID). LINKED TO MFG REPORT: 3004608878-2016-00329. ON (B)(6) 2016, A (B)(6) MALE PATIENT WAS UNDERGOING A CERVICAL SURGERY. HE WAS PINNED USING 60 POUNDS OF PRESSURE IN THE SUPINE POSITION. HE WAS PLACED ON THE A2114P MAYFIELD INFINITY XR2 SKULL CLAMP WITH THE METAL FREE CONVERSION RATCHET. ONCE THE PATIENT WAS POSITIONED INTO THE PRONE POSITION THE HEAD OF THE XR2 SYSTEM WAS LOCKED INTO POSITION USING THE 7 INCH EXTENSION LINK AND THE SINGLE STARBURST SWIVEL ADAPTOR. THE HEAD NEEDED TO BE REPOSITIONED SLIGHTLY AND THE BLUE AND YELLOW STARBURST REPOSITIONED AND THEN RE-LOCKED. AT THIS POINT THE METAL FREE RATCHET PIN AND STOP WHEEL BECAME LOOSE. IT WAS ALSO NOTED, BY THE SURGEON, THAT THE LOCKING KNOB DID NOT SEEM TO HAVE A DEFINITE CLICK AS DOES THE ALUMINUM MAYFIELD SKULL CLAMP. THERE WAS NO PATIENT INJURY. THE INCIDENT CAUSED A 20 MINUTE DELAY IN THE SURGERY WHILE THE XR2 SKULL CLAMP WAS SWAPPED OUT WITH REGULAR MAYFIELD SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787668 MAYFIELD XR2 METAL-FREE CONVERSION ADAPTOR-POOL UNIT N/A FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR SKULL PINS