BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 2945278 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10050
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 20, 2010
    Report Date
    January 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW - THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE RECEIVED CONDITION VISUAL INSPECTION OF THE TAPERED U-JOINT DRIVER (PART # (B)(4)) INDICATED NO VISIBLE DAMAGE. THE FUNCTIONAL INVESTIGATION INDICATED THE POSITION MEMORY OF THE U-JOINT WAS REDUCED DUE TO WORN OUT PEEK-BUSHINGS AND PINS IN THE PIN-JOINTS. THE POSITION MEMORY CAN BE LOST DUE TO FORCIBLE USE OR WEAR AND TEAR. THIS COMPLAINT DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    DURING ALIF (ANTERIOR LUMBAR INTERBODY FUSION) L4 TO L5 PROCEDURE, SURGEON WAS USING THE TAPERED U-JOINT DRIVER AND IT LOST ITS MEMORY. SURGEON HAD TO CHANGE OUT THE DRIVER FOR A TOTAL OF 4 TIMES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PT. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44503 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN MAX SYNTHES GMBH 2625094

    Patients

    Seq Age Sex Outcome Treatment
    1