BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11/8 GREEN

    MDR report key: 3193311 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03654
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 25, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE GREEN COLOR CODING AT BOTH SLEEVES IS PARTIALLY FALLEN OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT THIS HAPPENED DURING REPROCESSING, EITHER BY INTENSE CLEANING OR AN AGGRESSIVE DETERGENT. WE HAVE NO OTHER COMPLAINTS REGARDING THESE ARTICLES. OUR INSPECTION OF THE ENCLOSED AIMING ARM DID NOT SHOW ANY DEVIATION FROM THE SPECIFICATION. A FUNCTION TEST WAS MADE AND THE DEVICE WAS FUNCTIONAL AS REQUIRED. WE WOULD APPRECIATE MORE DETAILED INFORMATION ABOUT THE ITEMS THAT ARE DAMAGED IN SUCH A CASE. THIS WOULD ALLOW A SPECIFIC AND FOCUSED INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLOR CODING IS DAMAGED ON THE PROTECTION AND DRILL SLEEVES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292651 PROTECT SLEEVE 11/8 GREEN LXH SYNTHES GMBH 2223458

    Patients

    Seq Age Sex Outcome Treatment
    1