BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3041428 · Received April 8, 2013

    Report

    Report Number
    2520274-2013-01836
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED ON (B)(6) 2012 THE SAGITTAL SAW ATTACHMENT HAD RUST COMING OUT OF IT. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEVICE WAS NOT USED DURING A SURGICAL PROCEDURE. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143779 SAGITTAL SAW ATTACHMENT HWE SYNTHES USA 10013

    Patients

    Seq Age Sex Outcome Treatment
    1