BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMATIC ROTO OSTEOTOME DRILL

    MDR report key: 2974604 · Received January 17, 2013

    Report

    Report Number
    1811755-2013-90079
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K863447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR CARTRIDGE ASSEMBLY AND DRIVESHAFT REQUIRED REPLACEMENT DUE TO THE OVERHEATING OF THE DEVICE, WHICH WAS LIKELY CAUSED BY USE OVER TIME. THE AFFECTED COMPONENTS WERE REPLACED. THE DRILL WAS CLEANED, LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER. THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    THE PNEUMATIC ROTO OSTEOTOME DRILL WAS RETURNED FOR SVC. UPON EVALUATION AT THE MFR, IT WAS FOUND TO OVERHEAT. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27318 PNEUMATIC ROTO OSTEOTOME DRILL GET STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK