BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE POWERED SAGITTAL SAW

    MDR report key: 7305763 · Received March 1, 2018

    Report

    Report Number
    7305763
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 27, 2018
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    PORTABLE POWERED SAW TO BE USED DURING THE CASE WAS FAULTY; THE CLUTCH WAS DAMAGED, CAUSING INADEQUATE CUTTING OF BONE, NECESSITATING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149457 PORTABLE POWERED SAGITTAL SAW GAF STRYKER INSTRUMENTS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR