BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    MDR report key: 3073288 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10780
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    December 20, 2011
    Report Date
    December 20, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE FLEXIBLE REAMER WAS RETURNED WITH REAMER HEAD BROKEN OFF. REAMER HEAD WAS NOT RETURNED. THE SHAFT OF THE FLEXIBLE REAMER HAS MANY CIRCULAR STRIATIONS NEAR THE DISTAL END. ON THE DISTAL PORTION OF THE REAMER WHERE THE REAMER HEAD BROKE OFF THERE IS A SPIRAL SHAPED CRACK. ALL MEASURABLE DIMENSIONS FALL WITHIN THE ALLOWABLE TOLERANCES SPECIFIED ON THE DRAWING. IT IS UNLIKELY THE DEVICE DESIGN CAUSED THE DEVICE TO FAIL IN THIS CASE. WITHOUT THE REAMER HEAD RETURNED IT IS IMPOSSIBLE TO EXAMINE IT TO DETERMINE IF IT MAY HAVE BEEN OUT OF SPECIFICATION OR OVERUSED AND IF THAT COULD HAVE LED TO THE DEVICE FAILURE. THIS CASE IS INDETERMINATE FROM A DESIGN STANDPOINT DUE TO A LACK OF INFORMATION AND THE SMALL NUMBER OF COMPLAINTS FOR THIS PART. THE MANUFACTURING EVALUATION SHOWED THAT THE 6.0MM FLEXIBLE MEDULLARY REAMER WAS MANUFACTURED BY PRECIMED TO THE SYNTHES SOURCE CONTROL DRAWING NUMBER 359.106, REVISION C, RELEASED ON MAY 14, 2001. THE LOT WAS MADE TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. THE C OF C IS DATED MAY 25, 2005. THE WELDING BETWEEN THE FLEXIBLE SHAFT AND THE REAMER BROKE DUE TO AN UNKNOWN CAUSE. THE HEADPIECE WAS NOT INCLUDED IN THE COMPLAINT PACKAGE. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING POSITION.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE SURGEON WAS REAMING, THE HEAD TWISTED LOOSE FROM THE SHAFT OF THE HUMERAL REAMER (359.108). NO HARM TO PATIENT, OR CASE DELAY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173278 7.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM HTO SYNTHES MONUMENT 2399040001

    Patients

    Seq Age Sex Outcome Treatment
    1