BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAM TIGHTENER SHAFT

    MDR report key: 2862203 · Received December 7, 2012

    Report

    Report Number
    1526439-2012-83245
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER OR SAMPLE WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS "FUNCTIONAL REPRESENTATION FROM R&D, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CAPA DEEMED NECESSARY. ONE RELATED COMPLAINT 12 MONTH-TO-DATE. COMPLAINT RATE HAS DROPPED FROM PREVIOUS YEAR. CONDITION OF TIP PRIOR TO BREAKAGE IS UNKNOWN. DEVICE RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    ONE LEVEL ACDF C3-4, DOCTOR DID A 6X8 VG2, THEN CHOSE A 12MM SKYLINE PLATE, DRILLED WITH A 14MM FIXED DRILL, THEN PLACED 4EA 16MM SELF TAPPING VARIABLE SCREWS. SCREWS WERE CHECKED WITH RADIOLOGY AND DOCTOR STARTED TO LOCK SCREWS WITH CAM TIGHTENER. THE TIP OF THE CAM TIGHTENER BROKE OFF IN THE FIRST CAM (LEFT C4 CAM). DOCTOR STATED THAT TIP HAD BROKE OFF AND WEDGED IN THE CAM. HE TRIED TO REMOVE BROKEN PIECE WITH A SMALL HOOK BUT IT WOULD NOT COME OUT. I SUGGESTED THAT WE REMOVE SCREWS AND REPLACE THE PLATE. DOCTOR SAID THAT THE TIP WAS FINE AND DID NOT FEEL THAT IT WAS GOING ANYWHERE. HE SWITCHED TIGHTENERS AND FINISHED LOCKING THE REMAINING THREE CAMS WITHOUT INCIDENCE. PRIOR TO CLOSING I ASKED AGAIN IF WE COULD REMOVE SCREWS AND REPLACE PLATE AND AGAIN THE DOCTOR REFUSED. SAMPLES ARE NOT BEING RETURNED. HOSPITAL IS RETAINING SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAM TIGHTENER SHAFT MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM NW121860

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR