BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 4309981 · Received December 9, 2014

    Report

    Report Number
    2520274-2014-15228
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Report Date
    November 12, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HSZ. 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. 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

    THE SYNTHES COMPLAINT HANDLING UNIT RECEIVED A MAUDE REPORT NUMBERED (B)(4) VIA STANDARD MAIL ON (B)(6) 2014. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795718 2.5MM DRILL BIT/QC/GOLD/110MM BIT,DRILL HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1