BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT/MINI QC/80MM

    MDR report key: 3131969 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02849
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS CORRECTED FROM (B)(6) 2013 TO (B)(6) 2013. THE USER FACILITY REPORTED THE CATALOG # TO BE: 3872861; THIS IS AN INVALID SYNTHES PART #. THE CORRECT CATALOG # IS 317.861.

    Description of Event or Problem · 1

    A 1.8MM DRILL BIT WAS DAMAGED DURING SURGERY ON (B)(6) 2013 WITH THE FRAGMENT BEING LEFT IN THE BODY OF THE TALUS. NO ADDITIONAL TIME WAS ADDED TO THE PROCEDURE AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    VOLUNTARY REPORT NUMBER: MW5030071 WAS RECEIVED. A COPY OF THE REPORT WILL BE INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234438 1.8MM DRILL BIT/MINI QC/80MM HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1