BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 16/11 F/PFNA BLADE

    MDR report key: 11752579 · Received April 30, 2021

    Report

    Report Number
    8030965-2021-03459
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819291300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE PROTECT SLEEVE 16/11 F/PFNA BLADE (P/N: 356.818, LOT #: 8083906) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL THREADS WERE STRIPPED. THERE WERE SCRATCHES/NICKS ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS NOT PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED THE DEVICE RECEIVED WAS STRIPPED, WHICH COULD HAVE CAUSED THE COMPLAINT CONDITION. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE PROTECT SLEEVE 16/11 F/PFNA BLADE (P/N: 356.818, LOT #: 8083906). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 356.818, LOT: 8083906, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 17 OCT 2012 A MANUFACTURING RECORD EVALUATION WAS P.ERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. 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. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE ATTEMPTING TO WIND BUTTRESS NUT (356.817) ON TO THREADED PROTECTION SLEEVE (356.818), IT WAS NOT WINDING ON. THE REPORTER STATES THAT IT REQUIRED SIGNIFICANT EFFORT AND TIME, BUT MANAGED EVENTUALLY. UNSURE OF WHEN DAMAGE OCCURRED AND OBVIOUS WEAR / DAMAGE TO THE THREADS ON THE PROTECTION SLEEVE THAT WERE PREVENTING THE NUT FROM WINDING ON. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 16/11 F/PFNA BLADE. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654279 PROTECT SLEEVE 16/11 F/PFNA BLADE GUIDE FZX SYNTHES GMBH 8083906 07611819291300

    Patients

    Seq Age Sex Outcome Treatment
    1 BUTTRESS/COMPR-NUT F/PFNA BLADE| PROTECT SLEEVE 16/11 F/PFNA BLADE