BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE L130 TAN

    MDR report key: 3161842 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03055
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    July 4, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. WE ARE NOT AWARE OF ANY OTHER COMPLAINT, WHERE A BLADE WAS STUCK, FOR BOTH ARTICLE AND LOT NUMBER. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. HOWEVER, WITHOUT THE MATERIAL NO FINAL CONCLUSION IS POSSIBLE AND THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. BASED ON THE ENCLOSED PICTURES OF THE BLOCKED DEVICES IT IS POSSIBLE THAT THE SLEEVE OF THE BLADE WAS NOT CORRECTLY ORIENTED DURING THE INSERTION. SUCH A MISS-ORIENTATION CAN LEAD TO A JAMMING OF THE BLADE IN THE PROTECTION SLEEVE. THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    PROXIMAL FEMORAL NAIL ANTIROTATION BLADE GOT STUCK IN THE PROTECTION SLEEVE DURING INSERTION. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262958 PFNA BLADE L130 TAN JDS SYNTHES GMBH 2542090

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR