BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 BASE UNIT

    MDR report key: 6987100 · Received October 30, 2017

    Report

    Report Number
    3004608878-2017-00305
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 19, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 08NOV2017 AS FOLLOWS: ON (B)(6) 2017, A (B)(6) MALE PATIENT WAS TO UNDERGO AN OSTEOTOMY OF THE MIDDLE FOSSA WITH DURAL TUMOR EXCISION. THE REPORTED EVENT DID NOT LEAD TO INCREASE OF THE SURGERY TIME. THE MEDICAL STAFF FINISHED THE PROCEDURE USING ANOTHER POSITIONING SYSTEM. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2017. THE REPORTED ERROR BY THE CUSTOMER WAS CONFIRMED. THE PART S437A2309 CLAMP KNOB ASSEMBLY WAS BROKEN. DEVICE HISTORY REVIEW: CAN NOT BE PERFORMED AT THIS TIME AS NO SERIAL NUMBER OR LOT# HAVE BEEN PROVIDED. CAPA HAS BEEN ISSUED TO FURTHER INVESTIGATE THIS REPORTED FAILURE AND AS SUCH A TREND ANALYSIS WILL BE CAPTURED IN THIS PROJECT. 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

    THE SCREW OF THE (B)(4) STANDARD KNOB ASSEMBLY (PART OF THE MAYFIELD INFINITY XR2 BASE UNIT A2079) BROKE DURING USE, WHEN THE FINAL USER WAS POSITIONING THE PATIENT. THE PATIENT WAS ANESTHETIZED AND THERE WAS NO PATIENT INJURY. THE SURGICAL PROCEDURE WAS PERFORMED. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766344 MAYFIELD INFINITY XR2 BASE UNIT MAYFIELD FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR