BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 7 DUAL TRIGGER ROTARY

    MDR report key: 3173058 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01395
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS DUPLICATED; IT WAS CONFIRMED THAT THE HANDPIECE HAD RUN-ON AS A RESULT OF CORROSION. THE REPORTED EVENT LIKELY OCCURRED DUE TO NON-RECOMMENDED CLEANING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WOULD RUN AFTER FINGER WAS REMOVED FROM TRIGGER. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM 7 DUAL TRIGGER ROTARY WOULD RUN AFTER FINGER WAS REMOVED FROM TRIGGER. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273070 SYSTEM 7 DUAL TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1