BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 RASP

    MDR report key: 2634054 · Received June 21, 2012

    Report

    Report Number
    9616680-2012-00470
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    STRYKER ORTHOAPEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SPECIFIC LOT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT HAS COMPLAINED ABOUT STRYKER EXETER-RASPS AND REPORTED THE FOLLOWING: THE CUSTOMER THINKS THAT THE RASPS ARE VERY DIFFICULT TO CLEAN. AFTER HAVING THEM THROUGH ULTRASOUND AND WASHING MACHINE THERE STILL ARE SOME BONE LEFT IN THE RASPS. THE BONE WILL ONLY COME OUT IF IT TWISTED WITH A NEEDLE OR SOMETHING SHARP, THEN THE RASP HAS TO BE WASHED AGAIN. THIS CLEANING PROCEDURE WILL MAKE RISK FOR THE STERILIZATION STAFF TO GET CUT OR STABBED WITH THE NEEDLE. OTHERWISE THE CLEANING PROCEDURE IS VERY LONG AS A RESULT OF NEEDS TO WASH THE RASP TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 RASP INSTRUMENT LXH STRYKER ORTHOAPEDICS CORK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other