BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIC-INSTR W/ALIGNMENT GUIDE F/FLAPFIX

    MDR report key: 3174023 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03454
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    August 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE INVESTIGATION OF THE COMPLAINED APPLICATION INSTRUMENT FOUND THAT THE HOLDING PIN OF THE ADJUSTING BAR BROKE IN HALF. WE ARE NOT ABLE TO RELIABLY DETERMINE THE REASON WHY AND WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION LED TO THE DAMAGE. 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. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. WHILE WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION LED TO THE DAMAGE, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXATION SET SCREW WAS DETACHED FROM THE APPLICATION INSTRUMENT. 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
    274319 APPLIC-INSTR W/ALIGNMENT GUIDE F/FLAPFIX HXQ SYNTHES GMBH 3690446

    Patients

    Seq Age Sex Outcome Treatment
    1