BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 3760759 · Received April 21, 2014

    Report

    Report Number
    9612488-2014-10104
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 24, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: OUR INVESTIGATIONS HAVE SHOWN THAT ONE PIN OF THE RETURNED SYNREAM FLEXIBLE SHAFT IS INDEED COMPLETELY BROKEN OFF. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS BREAKAGE. IT IS CLEARLY VISIBLE THOUGH THAT THIS INSTRUMENT HAS BEEN IN GOOD USE OVER THE YEARS; IT WAS MANUFACTURED IN JULY 2002. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE DURING THE LOADING PROCEDURE FINALLY LED TO THE BREAKAGE OF ONE PIN. NO PRODUCT FAULT COULD BE DETECTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE END OF THE REAMER SHAFT BROKE WHEN BEING LOADED ONTO A REAMER HEAD. THE SHAFT WAS UNABLE TO CONNECT TO THE REAMER HEAD SECURELY ONCE IT BROKE. THERE WAS A SECOND REAMER SHAFT IN THE SET AND THE SURGERY CONTINUED WITHOUT DELAY. THIS REPORT IS FOR 1 OF 2 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239965 SYNREAM FLEXSHAFT REAMER HTO SYNTHES BETTLACH 2029956

    Patients

    Seq Age Sex Outcome Treatment
    1