BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2941840 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04309
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED LEAKING COULD NOT BE DUPLICATED DURING THE DEVICE EVAL. HOWEVER, SHATTERED DRIVESHAFT BEARINGS WERE FOUND, WHICH MAY HAVE CAUSED THE DEVICE TO EMIT DRIVESHAFT BEARING FRAGMENTS. DURING THE DEVICE EVAL AT THE MFR FACILITY, THE DRILL WAS REPORTED TO BE OVERHEATING. THE SHATTERED DRIVESHAFT BEARINGS WERE IDENTIFIED AS A PROBABLE CAUSE OF THE OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS LEAKING BLACK LIQUID. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK