BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 5317893 · Received December 22, 2015

    Report

    Report Number
    9612488-2015-10649
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 6, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE SHOWS ABRADED COLOR AND MARKS ON BOTH FLANKS OF THE BODY SLEEVE ITSELF, NEVERTHELESS THE EVENT DESCRIPTION DESCRIBES THAT THE EVENT HAPPENED BEFORE USE ON PATIENT. THE DEVICE WAS IN UNLOCKED POSITION WHEN RECEIVED; THE LOCKING SCREW WAS SCREWED INTO THE SLEEVE BODY TOO FAR MAKING THE USE OF THE INSERTING INSTRUMENT IMPOSSIBLE. ONCE REMOVED THE LOCKING SCREW IN CORRECT POSITION THE DEVICE PASSED SUCCESSFULLY THE PERFORMED FUNCTIONAL TEST. THE BLADE PASSED THE BLADE BORE OF A TEST PFNA-II NAIL AND COULD BE LOCKED AND UNLOCKED AS FORESEEN. THE REVIEW OF THE MANUFACTURING DOCUMENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT 9180321 WAS MANUFACTURED IN OCTOBER 2014. WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT BUT WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. (B)(4). DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 06OCTOBER2014. EXPIRY DATE: 01OCTOBER2024. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN UNKNOWN PROCEDURE IT WAS NOTED THAT THE PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) BLADE COULD NOT BE LOCKED COMPLETELY AFTER THE SURGEON OPENED THE PACKAGE. HE CHANGED THE BLADE AND TOOK A NEW ONE TO COMPLETE THE SURGERY. THE BLADE WAS NOT USED ON THE PATIENT; THERE WAS NO PATIENT HARM AND NO DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845491 PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 9180321

    Patients

    Seq Age Sex Outcome Treatment
    1