BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/S(PS)BOX TRIAL SZ5

    MDR report key: 9240154 · Received October 25, 2019

    Report

    Report Number
    1818910-2019-112158
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    February 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295234739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2019-112121. 1818910-2019-112158 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-112121 WILL BE KEPT FOR INVESTIGATION PURPOSES. 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. THE RE-USABLE INSTRUMENT ASSOCIATED WITH THIS PRODUCT COMPLAINT INVESTIGATION HAS BEEN DISPOSITIONED BY THE RAYNHAM GDC REFURBISHMENT CELL PRIOR TO CUSTOMER QUALITY BEING MADE AWARE OF THIS ALLEGATION AND IS UNAVAILABLE FOR EXAMINATION. LATE COMPLAINT ENTRY AND COMPLAINT AGING FOR THIS INVESTIGATION IS THE RESULT OF CUSTOMER COMMENTS RECEIVED DURING THE REFURBISHMENT PROCESS EXPRESSING DISSATISFACTION. THESE COMMENTS WERE NOT EVALUATED FOR CONSIDERATION OF A COMPLAINT, BY THE GDC TEAM, AS REQUIRED BY THE BRIDGEWATER/RAYNHAM REFURBISH CENTER PROCEDURE. ASSOCIATED CORRECTIONS ARE FOUND WITHIN RAYNHAM REPROCESSING CELL COMPLAINT REPORTING CAPA-009443. DUE TO THE COMPLAINT AGE WHEN REPORTED TO CUSTOMER QUALITY, IN RELATION TO THE DATE THE RAYNHAM GDC REFURBISHMENT CELL PROCESSED AND DISPOSITIONED THE DEVICE, REQUESTS FOR ADDITIONAL INFORMATION WILL NOT BE EXECUTED AS NO PATIENT EVENTS WERE IDENTIFIED WITHIN THESE REFURBISHMENT REQUESTS. A MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE ALLEGATION AGAINST THE DEVICE COMBINED WITH THE AGE OF THE DEVICE INDICATE WEAR OR USE RELATED FAILURE RATHER THAN A POTENTIAL MANUFACTURING DEFECT. THE INVESTIGATION WOULD NOT BE ABLE TO DRAW ANY CONCLUSIONS AS TO ROOT CAUSE AS NO PRODUCT IS AVAILABLE TO BE ANALYZED. NO INFORMATION RECEIVED WITH THIS COMPLAINT UPON RECEIPT OR DURING THE REFURBISHMENT PROCESS WOULD INDICATE THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION IS NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT MAY BE RE-OPENED TO DOCUMENT THE ADDITIONAL INFORMATION AND EXPAND THE INVESTIGATION, AS NECESSARY. THIS COMPLAINT IS MONITORED THROUGH DEPUY POST MARKET SURVEILLANCE SEP 419.

    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

    SCREW STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033436 PFC*SIGMA C/S(PS)BOX TRIAL SZ5 KNEE INSTRUMENT : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US J0605 10603295234739

    Patients

    Seq Age Sex Outcome Treatment
    1