BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L80 TAN

    MDR report key: 3781529 · Received April 30, 2014

    Report

    Report Number
    9612488-2014-10131
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; HWC. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 THE BLADE WAS USED FOR A PROXIMAL FEMUR FRACTURE CASE. DURING THE OPERATION, THE SURGEON WAS CHECKING IF THE BLADE WAS UNLOCKED AFTER ATTACHING THE BLADE ONTO THE INSERTER. THE BLADE DID NOT WORK NORMALLY. THE SURGEON THEN TRIED TO LOCK THE BLADE AGAIN; HOWEVER UNSUCCESSFUL AND IT BROKE. THE OPERATION WAS COMPLETED USING A LONGER BLADE AS A SUBSTITUTE. THE WAS NO REPORT OF FRAGMENTS LEFT IN THE PATIENT OR A SURGICAL DELAY. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260408 PFNA-II BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES BETTLACH 8761450

    Patients

    Seq Age Sex Outcome Treatment
    1