BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RACK Ø6.5/7.3

    MDR report key: 3181772 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03741
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    August 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE SCREW RACK HAS SHOWN THAT THE SCALE FOR THE SCREW LENGTH WAS NOT ETCHED ACCORDINGLY. CONCLUSION: WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE FOR THIS PROBLEM BUT WE SUPPOSE THAT ONE STEP DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT PROPERLY. THIS IS CLEARLY A MANUFACTURING FAULT. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED IN ORDER TO GET THESE ITEMS OFF THE MARKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEASURING DEVICE ON TOP OF THE CANNULATED SCREW RACK DOES NOT MEASURE CORRECTLY. 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
    283507 RACK Ø6.5/7.3 FSM SYNTHES GMBH 3828998

    Patients

    Seq Age Sex Outcome Treatment
    1