BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 BASE UNIT

    MDR report key: 7041924 · Received November 17, 2017

    Report

    Report Number
    3004608878-2017-00316
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Report Date
    November 3, 2017
    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 NOVEMBER 21, 2017. COMPLAINT CONFIRMED VIA INSPECTION OF ITEM. WITH RESPECT TO THE COMPLAINT, IT WAS CONFIRMED THE RETURNED UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TEST. REPAIR RECEIVED A A2114 SKULL CLAMP WITH THE THREADS FROM THE STANDARD TORQUE KNOB ARE BROKE OFF IN THE LARGE STARBURST TEETH. DEVICE HISTORY REVIEW : THE DEVICE IN QUESTION WAS NOT RETURNED (BASE ASSEMBLY) AND ONLY THE KNOB FOR THE SWIVEL ADAPTER AND THE SKULL CLAMP. AS SUCH A DHR CAN NOT BE PERFORMED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. CAPA HAS BEEN ISSUED TO FURTHER INVESTIGATE THIS REPORTED FAILURE AND AS SUCH A TREND ANALYSIS WILL BE CAPTURED IN THIS PROJECT. ROOT CAUSE: INTEGRA LIFE SCIENCES THOROUGHLY INVESTIGATED THE COMPLAINT EVENT. THIS INVESTIGATION INCLUDED OUTSOURCED MATERIAL TESTING, STRESS ENGINEERING AND FRACTOGRAPHY. THE CONSENSUS OF INVESTIGATION FINDS THE MOST LIKELY ROOT CAUSE OF COMPLAINT EVENT IS: USER APPLIED TORQUE TO KNOB IN EXCESS OF MATERIAL STRENGTH OF SCREW THREAD OR COMBINATION OF USER TORQUE AND CLAMP SUPPORT LOAD EXCEEDING SCREW THREAD STRENGTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS POSITIONED IN AN A2114 MAYFIELD INFINITY XR2 RADIOLUCENT SKULL CLAMP AND A LOUD POP WAS HEARD. THE SURGEON STILL HAD THE CLAMP SUPPORTED. THE BOLT (PART OF THE MAYFIELD INFINITY XR2 RADIOLUCENT BASE UNIT A2079) CONNECTING THE THE SWIVEL TO THE SKULL CLAMP HAD BROKEN. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. NO REVISION OR MEDICAL INTERVENTION WAS REQUIRED. A DELAY IN SURGERY DUE TO PRODUCT PROBLEM WAS REPORTED. ADDITIONAL REQUEST FOR INFORMATION WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819244 MAYFIELD INFINITY XR2 BASE UNIT MAYFIELD FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1