BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 3070695 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10953
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 30, 2011
    Report Date
    December 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS NOT RECEIVED, AND THIS COMPLAINT WAS DEEMED INVALID FROM A DESIGN STANDPOINT.

    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. CORRECTED DATA: ORIGINAL AWARENESS DATE: 12/01/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF PROCEDURE ON A FOOT, THE DRILL BIT BROKE. ALL OF THE PIECES WERE RETRIEVED FROM THE PATIENT AND DISCARDED. THE SURGEON USED ANOTHER DRILL BIT TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT. THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171661 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM HTW SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR