BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 3191926 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04151
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 14, 2012
    Report Date
    August 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. OUR INVESTIGATIONS HAVE SHOWN THAT THE FLEXIBLE SHAFT IS BROKEN. THE FRACTURE FACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY. THE MEASURABLE DIMENSIONS OF THE FLEXIBLE SHAFT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO-ASIF SPECIFICATION. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO-ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD FOR NITINOL 55NI-45TI. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. THE LOT IN QUESTION WAS MANUFACTURED IN JANUARY 2010 AND WE ARE NOT AWARE OF ANY QUALITY RELATED ISSUES. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. BASED ON THE COMPLAINT DESCRIPTION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE AND CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THIS BREAKAGE. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEXIBLE SHAFT BROKE DURING SURGERY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294240 SYNREAM FLEXSHAFT HTO SYNTHES GMBH 2432318

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR