BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3760253 · Received April 19, 2014

    Report

    Report Number
    2520274-2014-10761
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    NI
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. THIS DEVICE WAS RETURNED FOR SERVICE HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE SAGITTAL SAW ATTACHMENT WOULD NOT OSCILLATE. THE EVENT WAS NOT RELATED TO SURGERY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239110 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE NI 3740

    Patients

    Seq Age Sex Outcome Treatment
    1