BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM

    MDR report key: 3853858 · Received June 6, 2014

    Report

    Report Number
    2520274-2014-00978
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    September 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COORDINATED BY SYNTHES ANSPACH. REPORT RECEIVED INDICATES THE REPORTERS COMPLAINT OF INTERMITTENT OPERATION COULD NOT BE CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WASN'T DUPLICATED. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNKNOWN SURGERY, IT WAS DISCOVERED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM IS HESITATING AND RUNNING INTERMITTENTLY. SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS NO DELAY HAPPENED IN SURGICAL PROCEDURE DUE TO REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY HARM TO PATIENT. THIS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332571 RECON SAGITTAL SAW WITH KEY FOR TRAUMA RECON SYSTEM GEY SYNTHES GMBH 001531

    Patients

    Seq Age Sex Outcome Treatment
    1