BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11111

    MDR report key: 3072419 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-11111
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    August 31, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. INFORMATION FOR THIS EVENT WAS REPORTED THROUGH USER FACILITY MEDWATCH 3500A NUMBER (B)(4). PLACEHOLDER.

    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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS REPORTED TO BE AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT HAND THE DRILL BIT PART NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF PROCEDURE, THE SURGEON NOTED THAT THE DRILL BIT WAS BROKEN, THE SURGEON REMOVED THE DRILL BIT PIECE. THE MINI C-ARM IMAGE WAS TAKEN AND REVIEWED BY SURGEON WHO STATED DRILL BIT PIECE HAS BEEN RETRIEVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174262 HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR