BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY CMW 3 40G

    MDR report key: 7318444 · Received March 6, 2018

    Report

    Report Number
    1818910-2018-54633
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 22, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US 1818910
    Product Code
    LOD
    UDI-DI
    10603295168638
    PMA / PMN Number
    K053003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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). INVESTIGATION SUMMARY: COMPLAINTS RECEIVED BY CMW IN THE LAST 12 MONTHS FOR THIS ISSUE ¿ BY PRODUCT CODE: BY PRODUCT FAMILY: 13 (6X DEPUY CMW3, 7X ENDURANCE) STORAGE CONDITIONS CHECKED: NOT ABLE TO CHECK STORAGE CONDITIONS ONCE PRODUCT HAS BEEN DISPATCHED FROM SITE AND THERE IS NO CHECKLIST FROM THE HOSPITAL ATTACHED TO THE PROVIDED COMPLAINT INFORMATION. PRODUCT CHECKED: NO FMEA REVIEWED: DVA-107020-FDE REV 6 IFU / LABEL CHECKED: IFU-0630003 REV B PHOTOGRAPHS ATTACHED: NO THE COMPLAINT STATES ¿IT WAS REPORTED VIAL OF DEPUY 3 BROKE WHILE OPENING AND THE GLASS FELL INTO THE LIQUID. IT WAS NOT USED. NO BROKEN PIECES OF INSTRUMENTATION LEFT IN PATIENT. NO SURGICAL DELAY.¿ IT HAS BEEN NOTED, THAT APPLYING TOO MUCH PRESSURE DURING THE SNAPPING OF THE AMPOULE SEAL COULD POTENTIALLY LEAD TO THE BREAKING OF GLASS INTO THE AMPOULE OR FLAKING GLASS PARTICLES. THE IFU (IFU-0630003 REV B) CONTAINS ADVICE IN THE PRECAUTIONS SECTION TO BREAK THE AMPOULE AWAY FROM THE MIXING DEVICE TO PREVENT POSSIBLE CONTAMINATION FROM BROKEN AMPOULE GLASS (SEE ATTACHMENT (B)(4) IFU-(B)(4) REV B.PDF). THERE HAS BEEN NO CHANGE TO THE SPECIFICATION RELATING TO AMPOULE DIMENSIONS IN THE LAST 3 YEARS. REVIEW OF DVA-107020-FDE REV 6 CONTAINS THIS AND SIMILAR FAILURE MODES IN LINES 114-116, 118 AND 126 TO 127 (SEE ATTACHMENT ¿EXTRACT FROM DVA-107020-FDE REV 6.PDF¿). THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED, AS THERE IS NO INFORMATION INDICATING FAULT WITH THE AMPOULE (EG LEAKING MONOMER, A STRONG ODOUR OF MONOMER OR DISCOLOURED PACKAGING). DEVICE HISTORY LOT: DHR REVIEWED 1 UNRELATED NON-CONFORMANCE ON THIS BATCH. FINAL MICRO AND STERILITY TESTS PASSED. COMPLAINTS REVIEW A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBER FOUND 5 ADDITIONAL REPORTS RELATED TO AMPOULES BREAKING IRREGULARLY. THERE ARE AN ADDITIONAL 3 UNRELATED COMPLAINTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIAL OF DEPUY 3 BROKE WHILE OPENING AND THE GLASS FELL INTO THE LIQUID. IT WAS NOT USED. NO BROKEN PIECES OF INSTRUMENTATION LEFT IN PATIENT. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159421 DEPUY CMW 3 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 1818910 8628604 10603295168638

    Patients

    Seq Age Sex Outcome Treatment
    1