BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 2945277 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10051
    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 #03.802.341) 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 02/2012. 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 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43940 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN MAX SYNTHES GMBH 2625094

    Patients

    Seq Age Sex Outcome Treatment
    1