BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2130365 · Received May 9, 2011

    Report

    Report Number
    1811755-2011-01662
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RETURNED TO THE MFR FOR EVAL. DURING TESTING IT WAS IDENTIFIED THAT THE HANDPIECE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE. THE CONTACT PINS WERE BURNT, AND THERE WAS INSUFFICIENT LUBE IN THE BEARING ON THE ROTOR AND DRIVESHAFT. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WAS RUNNING HOT. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK