BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE PIN COLLET

    MDR report key: 3132571 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01216
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION SCORE MARKS WERE FOUND ON THE DRIVESHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ADJUSTABLE PIN COLLET HAD METAL SHAVINGS COMING OUT OF THE DEVICE. THE SURGEON STATED THAT THE SHAVINGS STAYED ON THE PIN AND THE HANDPIECE. THE SURGEON TAPPED THE HANDPIECE ON A PIECE OF GAUZE AND THE SHAVINGS CAME OFF: NO SHAVINGS ENTERED THE SURGICAL SITE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ADJUSTABLE PIN COLLET HAD METAL SHAVINGS COMING OUT OF THE DEVICE. THE SURGEON STATED THAT THE SHAVINGS STAYED ON THE PIN AND THE HANDPIECE. THE SURGEON TAPPED THE HANDPIECE ON A PIECE OF GAUZE AND THE SHAVINGS CAME OFF: NO SHAVINGS ENTERED THE SURGICAL SITE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234589 ADJUSTABLE PIN COLLET INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1