BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRINICA ATO INSTRUMENT

    MDR report key: 575014 · Received February 10, 2005

    Report

    Report Number
    2184052-2005-00002
    Event Type
    Other
    Date Received
    February 10, 2005
    Date of Event
    January 21, 2005
    Report Date
    February 10, 2005
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING 2 LEVEL, C5 TO C7, TRINICA CERVICAL FIXATION SYSTEM. OPON REMOVAL OF THE TRINICA SWIVEL ATO DRILL GUIDE THE ALIGMENT STAND BROKE OFF OF THE INSTRUMENT, WITHIN THE SURGICAL FIELD. THE ATTENDING SALES REP STATED THAT THE SURGEON HAD VERY CLEAR VISION OF THE BROKEN PIECE IN THE HEX POCKER OF THE LOCKING CAP ON THE PLATE. THE SURGEON THEN USED SUCTION TO REMOVE THE PIECE FROM THE FIELD. AFTER SUCTIONING, THE BROKEN PIECE WAS NO LONGER VISIBLE WITHIN THE HEX POCKET OF THE LOCKING CAP. REVIEW OF THE SUCTION DEVICE COULD NOT CONFIRM THE REMOVAL OF THE BROKEN PIECE. THE SURGEON THEN PROCEEDED TO WASH THE WOUND SEVERAL TIMES, AND USED SUCTION, IN ATTEMPTS TO RETRIEVE THE BROKER PIECE IN CASE IT HAD MIGRATED FROM ITS ORIGINAL LOCATION. A SECOND REVIEW OF THE SUCTION DEVICE AGAIN COULD NOT CONFIRM THE REMOVAL OF THE BROKEN PIECE. POST OP X-RAYS TAKEN DID NOT REVEAL ANY FOREIGN MATERIAL. THE BROKEN PIECE IS VERY SMALL, APPROXIMATELY .097 X .084", AND COULD HAVE BEEN OVERLOOKED DURING INSPECTION OF THE SUCTION INSTRUMENT (S). AS OF THE DATE OF THIS REPORT THE PATIENT HAS NOT REPORTED ANY PROBLEMS AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA ATO INSTRUMENT TRINICA ATO SWIVEL DRILL GUIDE HXY ZIMMER SPINE, INC. 07.00796.001 P040129

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other