BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM

    MDR report key: 3971248 · Received July 31, 2014

    Report

    Report Number
    8030965-2014-00544
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    September 10, 2013
    Report Date
    September 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. POWER TOOL EVALUATION WAS COMPLETED FOR THIS DEVICE. THE REPORTER'S COMPLAINT THAT THE UNIT WILL NOT ROTATE COULDN'T BE CONFIRMED. THE DEVICE WAS TESTED AND THE COMPLAINT WASN'T DUPLICATED. PLACEHOLDER.

    Description of Event or Problem · 1

    FACILITY REPORTED SAGITTAL SAW WOULD NOT TURN TO CUT. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE (B)(4) 2013 FACILITY REPORTED DURING SURGERY THE SAGITTAL SAW WOULD NOT TURN TO CUT. UPDATE (B)(4) 2013 FACILITY REPORTED DURING SURGERY THE SAGITTAL SAW WOULD NOT TURN TO SAW AND HAD TO GET A SPARE DEVICE WHICH CAUSED A DELAY IN SURGERY, PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 OF COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446752 LID FOR RECON SAGITTAL SAW FOR TRAUMA RECON SYSTEM GEY SYNTHES GMBH 001704

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR