BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3070064 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10984
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 5, 2011
    Report Date
    December 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. (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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTED: THE REAMER HEAD BROKE INTO TWO FRAGMENTS WHEN SURGEON WAS COMPLETING A FEMORAL IM REAMING PROCEDURE (RETROGRADE THROUGH THE KNEE). SURGEON WAS ABLE TO RETRIEVE BOTH FRAGMENTS. NO FRAGMENTS WERE LEFT IN THE PATIENT. REPORTEDLY, THE REAMER WAS USED ON AN ANGLE, NOT ALIGNED STRAIGHT WITH THE REAMING ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171397 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 1513424

    Patients

    Seq Age Sex Outcome Treatment
    1