BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    MDR report key: 3020891 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10437
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 2, 2012
    Report Date
    February 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. FLEXIBLE REAMER WAS RECEIVED IN ONE PIECE. THE PROXIMAL END COUPLING OF THE REAMER HAS MANY DEEP CIRCULAR STRIATIONS. THERE IS ALSO A SMALL CAP THAT IS WELDED WHERE THE PROXIMAL COUPLING PIECE MEETS THE FLEXIBLE SHAFT THAT HAS DETACHED FROM THE PROXIMAL COUPLING PIECE. THERE ARE MODERATE CIRCULAR STRIATIONS AROUND THE LENGTH OF THE FLEXIBLE SHAFT. THE REAMER HEAD IS IN GOOD CONDITION AND THE CUTTING EDGES ARE FAIRLY SHARP.

    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. EVENT DESCRIPTION UPDATED. ORIGINAL AWARENESS DATE IS 2/3/12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEXIBLE MEDULLARY FELL APART DURING A TFN PROCEDURE. NOTHING BROKE OFF INTO THE PATIENT, THERE WAS NOTHING TO RETRIEVE. THE SURGEON COMPLETED THE PROCEDURE, THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123395 8.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM HTO SYNTHES MONUMENT 2150940001

    Patients

    Seq Age Sex Outcome Treatment
    1