BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 3171562 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03391
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    May 30, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 COMPLAINED DEVICE BY OUR PRODUCT DEVELOPMENT ENGINEER COULD NOT IDENTIFY THE ROOT CAUSE FOR THE REPORTED PROBLEM. THE FUNCTIONAL TEST PERFORMED COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATIONS. AFTER DISASSEMBLING, ALL PARTS WERE FOUND IN FAULTLESS CONDITION. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON CAUSING THE REPORTED PROBLEM. 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. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP IS BROKEN OFF AND THE FRAGMENT WAS REMOVED. THE DOCTOR INSERTED THE COMPRESSION BLADE INTO THE FEMORAL HEAD BY HITTING IT, THEN HE TRIED TO LOCK THE BLADE BUT HE COULD NOT. HE HEARD SOME MECHANICAL SOUND LIKE A CLICKETY-CLACK. HE REMOVED TO CHECK THE BLADE AND AS A RESULT THE BLADE WAS NOT LOCKING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272580 PFNA-II BLADE L90 TAN HRS SYNTHES GMBH 2713003

    Patients

    Seq Age Sex Outcome Treatment
    1