BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ WIRE COLLET 0.7-1.8MM

    MDR report key: 2955049 · Received February 11, 2013

    Report

    Report Number
    0001811755-2013-00242
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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 DEVICE HAD METAL SHAVINGS LOCATED BY THE DRIVESHAFT AND NOTED THE DRIVESHAFT HAD SCORE MARKS. ACCORDING TO A REVIEW OF THE RISK DOCUMENTS, WEAR ON THE DRIVESHAFT MAY 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 WIRE COLLET 0.7-1.8MM WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THERE WAS METAL SHAVINGS ON THE DRIVESHAFT AND LEVER OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE ADJ WIRE COLLET 0.7-1.8MM WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THERE WAS METAL SHAVINGS ON THE DRIVESHAFT AND LEVER 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
    59177 ADJ WIRE COLLET 0.7-1.8MM INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1