BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNEX SPREADER F/MIS

    MDR report key: 3151248 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02755
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE WELD ATTACHING THE KNURLED KNOB TO THE CONNECTING SCREW HAS BROKEN. MACROSCOPIC SIGNS OF PITTING ON THE KNURLED KNOB INDICATE THE SPREADER WAS SUBJECTED TO MECHANICAL STRAIN WHICH CAUSED THE WELDED SEAM TO FAIL. 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. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND WE HAVE TO ASSUME THAT MECHANICAL STRAIN WAS APPLIED TO THE DEVICE AND CAUSED THE BREAKAGE. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ASSUME THAT THE COMPLAINT CONDITION IS DUE TO MECHANICAL STRAIN APPLIED TO THE DEVICE WHICH CAUSED THE BREAKAGE AND THEREFORE USER ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KNOB OF THE CONNECTION SCREW FELL OFF. THE INSTRUMENT HAD ONLY JUST BEEN REPAIRED BY SYNTHES AND FELL APART DURING THE FIRST USE. THE END OF THE INNER SHAFT CAME APART. 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
    250743 SYNEX SPREADER F/MIS HTD SYNTHES GMBH 3300747

    Patients

    Seq Age Sex Outcome Treatment
    1