BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPORARY FIXATION PIN

    MDR report key: 3831566 · Received May 25, 2014

    Report

    Report Number
    2520274-2014-11603
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME HWD. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE DRAWING FOR THE TEMPORARY FIXATION PIN WAS REVIEWED (324_101 REV E). THE DRAWING WAS FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE SCREW HEAD MET ALL DIMENSIONAL SPECIFICATIONS STATED IN THE MANUFACTURING DRAWING. THE TREADED PORTION OF THE PIN WAS NOT RETURNED AND THEREFORE COULD NOT BE EVALUATED. THE PRODUCT WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿BROKEN: INTRAOPERATIVELY¿. THE COMPLAINT DESCRIPTION STATES THAT WHILE INSERTING THE TEMPORARY FIXATION PIN INTO THE RIGHT C6 HOLE OF THE PLATE, THE PIN BROKE OFF FLUSH WITH THE C6 VERTEBRAL BODY. IT WAS NOTED THAT THE PATIENT HAD SCLEROTIC BONE AT THE C6 LEVEL. THE FRAGMENT WAS NOT REMOVED AS THE SURGEON DID NOT WANT TO REMOVE BONE FROM THE C6 VERTEBRAL BODY. WITH THE SCLEROTIC BONE NOTED, IT IS LIKELY THAT THE RESULTING INCREASED BONE GROWTH AND DENSITY DIRECTLY LED TO THE PART FAILURE. IT IS LIKELY THAT AN EXCESSIVE FORCE WAS APPLIED TO THE PIN IN AN ATTEMPT TO COMPENSATE FOR THE OVERLY DENSE BONE WHICH CAUSED THE PIN TO BREAK. AFTER REVIEW THE RELATED PRODUCT DRAWINGS AND COMPLAINT HISTORY, THE DESIGN DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE FAILURE WAS A RESULT OF A MECHANICAL OVERLOAD CAUSED BY A MEDICAL CONDITION WHICH LED TO AN INCREASE IN BONE THICKNESS AND DENSITY. AS THE DEVICE DID BREAK, THE COMPLAINT IS CONFIRMED; HOWEVER IT IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A C4-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING A CERVICAL SPINE LOCKING PLATE (CSLP). HE SIZED THE CSLP PLATE AND DECIDED TO USE A 60MM PLATE. HE BENT THE PLATE AND THEN ATTEMPTED TO INSERT A VECTRA TEMPORARY FIXATION PIN WITH A DRIVER IN THE RIGHT, C6 HOLE OF THE PLATE. THE PATIENT HAD SCLEROTIC BONE AT THE C6 LEVEL. WHEN THE TEMPORARY FIXATION PIN WAS NEARLY SEATED, IT BROKE OFF FLUSH WITH THE C6 VERTEBRAL BODY. THE SURGEON DID NOT WANT TO TRY AND RETRIEVE THE FRAGMENT. HE ALSO DID NOT WANT TO REMOVE ANY BONE FROM THE C6 VERTEBRAL BODY THAT WOULD WEAKEN HIS C6 SCREW FIXATION. HE PLACED ALL OF HIS SCREWS IN THE PLATE AND THEN DRILLED THE RIGHT C6 HOLE. THE SURGEON THEN ATTEMPTED TO PLACE THE SCREW AND THE TEMPORARY PIN FRAGMENT WOULD NOT ALLOW THE SCREW TO SEAT, SO HE TAPPED WITH A 4.35MM TAP AND TRIED A NEW SCREW AND IT STILL DID NOT SEAT IN THE PLATE PROPERLY. THE SURGEON TRIED ANOTHER NEW SCREW, IT ALSO DID NOT SEAT PROPERLY. HE THEN USED A MIDAS REX HIGH SPEED BURR TO DRILL AWAY SOME OF THE TEMPORARY FIXATION PIN FOLLOWED BY SUCTION IN THE HOLE, THE SURGEON WAS ABLE TO INSERT A NEW PROPERLY SEATED SCREW. THE PROCEDURE WAS COMPLETED, THE TEMPORARY FIXATION PIN FRAGMENT REMAINED IN THE PATIENT AND WAS POSITIONED CAUDAL TO THE RIGHT C6 CSLP SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309821 TEMPORARY FIXATION PIN GUIDE FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR