BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO LARGE FIXED DURAGUARD

    MDR report key: 3070098 · Received April 22, 2013

    Report

    Report Number
    0001811755-2013-00850
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF OVERHEATING WAS DUPLICATED AND CONFIRMED. VISUAL INSPECTION DURING DISASSEMBLY CONFIRMED DEBRIS AFFECTING THE BEARINGS AND FRONT BEARING SLEEVE. DEBRIS CAN CAUSE THE BEARINGS TO WEAR AND GRADUALLY LOSE THEIR ROTATIONAL PROPERTIES THROUGH DEGRADATION, WHICH CAN CAUSE FRICTIONAL HEAT. THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION. DURING EVALUATION, IT WAS CONFIRMED THAT THE DURAGUARD WAS NOT BENT. THEREFORE, CORRECTIONS HAVE BEEN MADE TO EXECUTIVE SUMMARY AND DEVICE CODES TO REFLECT THIS FINDING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE DURA GUARD WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE DURA GUARD WAS OVERHEATING AND WAS BENT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171640 MAESTRO LARGE FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 06335

    Patients

    Seq Age Sex Outcome Treatment
    1