BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 125° F/PFNA BLADE

    MDR report key: 3173941 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03443
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    September 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    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. 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. APPARENTLY THERE WAS EVIDENCE WHICH REVEALED THAT OTHER PARTS THAT WERE NOT RETURNED OR REPORTED MAY HAVE BEEN THE CAUSE OF THE PROBLEM. NO FURTHER INVESTIGATIONS CAN BE PERFORMED. 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. THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH ALL SPECIFICATIONS AND NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. HOWEVER, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN. IT IS NOTED THAT OTHER PARTS THAT WERE NOT RETURNED OR REPORTED MAY HAVE BEEN THE CAUSE OF THE PROBLEM. NO FURTHER INVESTIGATIONS CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DATE OF THE EVENT WAS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIMING ARM COULD NOT FIT THE SLEEVE. 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
    273712 AIM-ARM 125° F/PFNA BLADE LXH SYNTHES GMBH 2120702

    Patients

    Seq Age Sex Outcome Treatment
    1