BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CAST CUTTER

    MDR report key: 2082115 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01415
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    PRE-AMEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT COULD NOT BE DUPLICATED. THE DEVICE WOULD NOT POWER ON AND HAD A MELTED BACK CAP AROUND THE BRUSH HOLDERS. THIS WAS LIKELY WHAT THE CUSTOMER SAW BUT COULD NOT BE DUPLICATED BECAUSE THE DEVICE DID NOT POWER ON. THE BACK CAP AS WELL AS THE BRUSH HOLDERS WERE REPLACED, AND THE DEVICE WAS RETURNED TO THE CUSTOMER. THERE WERE NO PREVIOUS REPAIRS RELEVANT TO THE REPORTED EVENT BASED ON A REVIEW OF THE SERVICE HISTORY OF THIS DEVICE. NO ADVERSE TRENDS HAVE BEEN OBSERVED IN THE LAST (12) MONTHS OF COMPLAINT DATA. THE DEVICE WAS REPAIRED AND RETURNED TO THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW WAS SMOKING FROM THE SWITCH WHILE IN USE. THEY STOPPED USING IT AND USED A BACKUP SAW. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOANER CAST CUTTER HAB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK