BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMVAC 1 PIECE GUN

    MDR report key: 14428726 · Received May 18, 2022

    Report

    Report Number
    1818910-2022-09039
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 17, 2022
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    JDK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    THE HOSPITAL HAVE REPORTED A BROKEN CEMENT GUN, THE RATCHET MECHANISM HAD BROKEN.

    Description of Event or Problem · 0

    A. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? IF YES, WAS THERE ANY SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? THERE WAS NO SURGICAL DELAY, THE DEVICE WAS TESTED BEFORE THE PATIENT CAME INTO THEATRE AND SO A DIFFERENT DEVICE WAS USED FOR SURGERY. B. DID IT BREAK INTO 2 OR MORE PIECES? NO THEY SAID THE RATCHET MECHANISM BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763870 CEMVAC 1 PIECE GUN DEPUY CMW CEMENTING ACCESSORIES : CEMENT DELIVERY DEVICES JDK DEPUY IRELAND - 3015516266

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown