BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ PIN COLLET 2.0-3.2MM

    MDR report key: 3731757 · Received April 7, 2014

    Report

    Report Number
    0001811755-2014-01209
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED SPARKING OF THE DEVICE WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. THE PRESENCE OF FLUID INSIDE A DEVICE CAN BE CAUSED BY IMPROPER OR NON-RECOMMENDED CLEANING PROCEDURES. UPON DISASSEMBLY IT WAS FOUND THAT A BEARING AT THE NOSE OF THE ATTACHMENT HAD SHATTERED, WHICH CAN CONTRIBUTE TO THE REPORTED EVENT. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPARKS WERE OBSERVED COMING FROM THE ADJ PIN COLLET 2.0-3.2 MM. THE ACCOUNT WAS UNABLE TO PROVIDE FURTHER DETAIL REGARDING THE EVENT. THERE WERE NO REPORTED PATIENT OR USER INJURIES AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPARKS WERE OBSERVED COMING FROM THE ADJ PIN COLLET 2.0-3.2 MM. THE ACCOUNT WAS UNABLE TO PROVIDE FURTHER DETAIL REGARDING THE EVENT. THERE WERE NO REPORTED PATIENT OR USER INJURIES AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209270 ADJ PIN COLLET 2.0-3.2MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1