BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 6273912 · Received January 24, 2017

    Report

    Report Number
    1818910-2017-11296
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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-0163-146 REV 3) CONTAINS ADVICE TO BREAK THE AMPOULE AWAY FROM THE MIXING DEVICE TO PREVENT POSSIBLE CONTAMINATION FROM BROKEN AMPOULE GLASS. DVA-107020-FDE REV 5, LINES 101 AND 119 (BAR) WHICH STATES THE POTENTIAL HAZARD: ¿DAMAGED DEVICE. DAMAGED GLASS AMPOULE DUE TO INADEQUATE PROTECTION FROM SECONDARY PACKAGING.¿ A STUDY WAS CONDUCTED AND HAS BEEN DOCUMENTED AS FOLLOWS: ¿TRANSIT STUDY VERIFICATION HAS BEEN COMPLETED TO ENSURE THE PACKAGING SYSTEM IS SUITABLE FOR USE AND REMAINS INTEGRAL. REFERENCE: RR-ENG-101349-TR ISTA 3A TRANSIT STUDY FOR AMPOULE BLISTER AND CARTON.¿ LINE103(BAR) STATES ¿MMA IS A STRONG SOLVENT AND AT THE TIME OF DEVELOPMENT GLASS AMPOULES WERE THE MOST SUITABLE PACKAGING VESSEL FOR LONG TERM STORAGE¿ (REPORT REFERENCE R374). A LIKELY ROOT CAUSE FOR THIS FAILURE MODE IS THAT A HAIRLINE FRACTURE WAS PRESENT IN THE AMPOULE, WHICH COULD HAVE OCCURRED FROM THE ¿BUMPING¿ OF AMPOULES ALONG THE PRODUCTION LINE DURING THE LIQUID FILLING PROCESS. THIS POSSIBLE FRACTURE COULD HAVE BEEN AMPLIFIED DURING TRANSIT DUE TO TRANSIT STRESSES, WHICH COULD HAVE RESULTED IN THE AMPOULE BREAKING IN A WAY NOT SEEN BY THE SURGICAL TEAM PREVIOUSLY. PREVIOUS EFFECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO IMPROVE THE PROTECTION OF AMPOULES DURING PACKING AND TRANSIT TO THE CUSTOMER. COMPLAINTS RECEIVED FOR THIS ISSUE WILL CONTINUE TO BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    GLASS FRAGMENTS BROKE OFF OF MV MONOMER (LIQUID) GLASS VIAL. FRAGMENTS FELL INTO THE POWDER IN THE MIXING BOWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57700 SMARTSET MV 40G - EO CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 8374100

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR