BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 RASP HANDLE

    MDR report key: 1905658 · Received November 12, 2010

    Report

    Report Number
    9616680-2010-00727
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA EMAIL THAT THEY HAVE AN ISSUE WITH DECONTAMINATING EXETER RASPS. THE CUSTOMER FURTHER REPORTED THAT THE RASPS ARE HAND DECONTAMINATED INITIALLY, BRUSHING WITH A RIGID BRUSH AND THEN A HIGH PRESSURE WASHER, THEY ARE THEN PLACED IN AN ULTRASONIC CLEANER TO DISLODGE ANY DEBRIS THAT MAY HAVE BEEN MISSED, THEY ARE THEN WASHED IN AN AUTOMATED WASHER/ DISINFECTOR BUT THERE IS MINUTE FRAGMENTS OF BONE INSITU RESULTING IN PT CASES BEING CANCELLED. THE CUSTOMER WOULD LIKE ADVISE ON THE BEST WAY TO WASH THE RASPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other