BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 2971620 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00566
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: COMPLAINT FOUND TO BE A DUPLICATE OF (B)(4) AND IS BEING RETRACTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A SAGITTAL SAW ATTACHMENT HAD RUST COMING OUT OF IT. THE DEVICE WAS NOT USED IN A SURGERY. THERE WERE NO PATIENT OR USER INJURIES REPORTED. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT IT IS A DUPLICATE OF (B)(4) FOR WHICH MW#2520274-2013-01836 WAS SUBMITTED. THEREFORE, THIS COMPLAINT IS BEING RETRACTED AND (B)(4) WILL REMAIN THE OFFICIAL COMPLAINT OF RECORD. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75935 SAGITTAL SAW ATTACHMENT SAW ATTACHMENT HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1