BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3070850 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10966
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. MANUFACTURING SITE ADDRESS IS UNKNOWN. (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN INTRAMEDULLARY NAIL IMPLANT OF A TIBIA THE SURGEON WAS REAMING, THE FIRST PASS, THE REAMER CAME IN CONTACT WITH THE POSTERIOR CORTEX. WITH SUBSEQUENT FORCE, USING POWER, THE REAMER MOVED FORWARD, HOWEVER ON X-RAY, IT WAS DISCOVERED THAT THE REAMER HEAD HAD BROKEN INTO 3 PIECES WITHIN THE MEDULLARY CANAL. THE SURGEON EXTRACTED ALL 3 PIECES. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENT AND WITH NO ADVERSE EFFECT TO PATIENT NOTED. THE PART DISCARDED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171472 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR