BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP 3DEG SYM CUT BLK

    MDR report key: 9241567 · Received October 25, 2019

    Report

    Report Number
    1818910-2019-112344
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JWH
    UDI-DI
    10603295225133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    PIN STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037539 SIGMA HP 3DEG SYM CUT BLK KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES JWH DEPUY INTERNATIONAL LTD - 8010379 PG0410 10603295225133

    Patients

    Seq Age Sex Outcome Treatment
    1