BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L120 TAN

    MDR report key: 3830317 · Received May 23, 2014

    Report

    Report Number
    9612488-2014-10193
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE COMPLAINT PROXIMAL FEMORAL NAIL ANTIROTATION BLADE WAS INVESTIGATED TOGETHER WITH THE RESPONSIBLE PRODUCT MANAGER FOR CONFORMITY. THE EVALUATION HAS SHOWN THAT THE PART SHOWS SOME WEAR MARKS AT THE SHAFT. THE BLADE SHOWS NO OTHER DAMAGE OR DEVIATION. THE ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND IS FULLY FUNCTIONAL. THE REVIEW REVEALED THAT THE ARTICLE WAS MANUFACTURED IN NOVEMBER 2013 ACCORDING TO THE SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IT APPEARS THAT THERE WAS A TECHNICAL COMPLICATION DURING INSERTION. NO PRODUCT FAULT COULD BE DETECTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS JAMMING SO IT WAS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A FEMORAL NAIL INSERTION ON (B)(6) 2014, THE HELICAL BLADE STICKS/JAMS/STUCK WITH THE NAIL. DURING THE SURGERY THE TEAM HAD TRIED TO PUT THE BLADE IN TO THE NAIL, BUT IT SEEMED TO JAM. THEREFORE THE SURGEON REPLACED THE BLADE WITH A NEW BLADE OF SAME LENGTH AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE IS NO REPORT OF A TIME DELAY AND NO REPORT OF AN INJURY TO THE PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307730 PFNA BLADE PERF L120 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 8730777

    Patients

    Seq Age Sex Outcome Treatment
    1