BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN COLLET

    MDR report key: 3061312 · Received April 16, 2013

    Report

    Report Number
    0001811755-2013-00810
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, WIDESPREAD CORROSION WAS DISCOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLACK POWDER CONTAINING METAL SHAVINGS WAS OBSERVED COMING OUT OF THE TIP OF THE COLLET DURING A PODIATRY PROCEDURE. IT WAS CONFIRMED THAT NONE OF THE BLACK POWDER ENTERED THE SURGICAL SITE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162854 PIN COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1