BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ PIN COLLET 2.0-3.2MM

    MDR report key: 2964598 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00296
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY SPECIALIST CONFIRMED THE REPORTED EVENT AND NOTED METAL SHAVINGS WERE FOUND AND THE DRIVESHAFT HAD SCORE MARKS. ACCORDING TO A REVIEW OF THE RISK DOCUMENTS, WEAR ON THE DRIVESHAFT CAN PRODUCE METAL SHAVINGS. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS DUE TO DRIVESHAFT SCORING.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ADJ PIN COLLET 2-2.3MM WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THERE WERE METAL SHAVINGS PRESENT ON THE SHAFT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE ADJ PIN COLLET 2-2.3MM WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THERE WERE METAL SHAVINGS PRESENT ON THE SHAFT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66473 ADJ PIN COLLET 2.0-3.2MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1