BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-LARGE

    MDR report key: 3033544 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-01346
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RIGHT HAND TIP OF THE UPPER ARM WAS BROKEN OFF. THE INSERTER CORRESPONDS TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. TOO MUCH FORCE WAS APPLIED TO THE TIP CAUSING IT TO BREAK. THE HARDNESS WAS REINSPECTED AND FOUND TO BE GOOD AT 48.5HRC. THE INSERTER IS OVER 7 YEARS OLD. (B)(4). SYNTHES RECEIVED THE INSTRUMENT OF THIS COMPLAINT IN JULY OF 2006. THE FABRICATION OF THIS INSTRUMENT PREDATES THE MATERIAL CHANGE RESULTING FROM (B)(4). THE CHU REVIEWED THE LOT HISTORY FOR ALL THE INSTRUMENTS IN THE COMPLAINT HISTORY. ALL OF THESE INSTRUMENTS PREDATE THIS MATERIAL CHANGE. THE TESTING CONDUCTED FOR (B)(4) SHOWS THAT A MATERIAL CHANGE INCREASES THE RESISTANCE TO THIS FAILURE MODE BY MORE THAN 50 PERCENT. THE (B)(4) REPORTED A COMPLAINT REDUCTION OF GREATER THAN 75 PERCENT, 9/2008 TO 8/2010, FOR THIS FAILURE MODE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING PDL IMPLANT SURGERY, L4-S1, ON (B)(6) 2013, THE TIP OF THE INSERTER THAT CONNECTS INTO THE PRODISC BROKE. THE PIECE WAS RETRIEVED AND THROWN AWAY. THE SURGEON USED SMALL FORCEPS TO PULL OUT THE PIECE FROM THE IMPLANT. ANOTHER INSERTER WAS USED AND THE REMAINDER OF THE SURGERY WENT FINE. THE SURGERY WAS PROLONGED APPROXIMATELY 5 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137504 INSERTER-LARGE LXH SYNTHES GMBH A7PA26

    Patients

    Seq Age Sex Outcome Treatment
    1