BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 7 HIGH SPEED PRECISION SAW

    MDR report key: 3822972 · Received May 21, 2014

    Report

    Report Number
    0001811755-2014-01840
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORTED EVENT, PART THAT HOLDS BLADE CAME OFF, WAS CONFIRMED. DURING THE SERVICE EVALUATION IT WAS DETERMINED THAT THE TD-OST UNTHREADED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PIECE FROM THE SYS 7 HIGH SPEED PRECISION SAW THAT HOLDS THE BLADE DISASSEMBLED. THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PIECE FROM THE SYS 7 HIGH SPEED PRECISION SAW THAT HOLDS THE BLADE DISASSEMBLED. THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, SO THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301395 SYS 7 HIGH SPEED PRECISION SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1