BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3053502 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10631
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER THE DRILL BITS (310.25) ARE RUSTING. THERE WAS NO PATIENT INVOLVEMENT. DEVICE WILL NOT BE RETURNED AND THE LOT NUMBER FOR DRILL BIT IS UNOBTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156154 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT U144663

    Patients

    Seq Age Sex Outcome Treatment
    1