BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLRY-HD RNGLC SHL 48MM/L22

    MDR report key: 7218000 · Received January 25, 2018

    Report

    Report Number
    3002806535-2018-00176
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 15, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET (B)(4) FOR EVALUATION AND FORWARDED TO THE COMPLAINTS AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS: ON RECEIVING THE MALLORY SHELL FROM ZIMMER BIOMET (B)(4), THE FOLLOWING OBSERVATIONS HAVE BEEN FOUND: THE DEVICE POUCH IS DAMAGED ON ALL RETURNED DEVICES, WHERE THE DEVICE FIN HAS CREATED A HOLE IN THE POUCH. NO DAMAGE HAS BEEN FOUND ON THE EXTERNAL WALL OF THE BLISTER. SCORING ON THE INTERNAL WALL OF THE BLISTER HAS BEEN FOUND. NO DAMAGE HAS BEEN FOUND ON THE INTERNAL WALL OF THE CARDBOARD CARTON. FOAM PARTICLES ARE EVIDENT ON THE POUCH ON ALL RETURNED DEVICES. ALL PRIMARY STERILE BARRIERS (TYVEK TO BLISTER SEAL) ARE COMPLETE AND NOT DAMAGED. ALL LABELLING INFORMATION IS CORRECT. THE RETURNED DEVICES WERE WITHIN THEIR DEFINED SHELF LIFE. I.E. NOT EXPIRED. DOCUMENTATION REVIEW: THE MANUFACTURING RECORDS HAVE BEEN CHECKED FOR MANUFACTURING REVIEW, REWORK AND SCRAP ACTIVITIES. WITH THE FOLLOWING OBSERVATIONS: 3541094: 6 DEVICES ON MANUFACTURING RUN. ALL DEVICES HAVE BEEN PACKAGED WITH NO DEVIATION, SCRAP OR REWORK RECORDED OR FOUND. 388004: 6 DEVICES ON MANUFACTURING RUN. ALL DEVICES HAVE BEEN PACKAGED WITH NO DEVIATION, SCRAP OR REWORK RECORDED OR FOUND. BILL OF MATERIALS ON SAP HAS BEEN CHECKED AGAINST THE MANUFACTURING HISTORY RECORD WITH NO DEVIATIONS FOUND. THE DEVICES HAVE BEEN VISUALLY EXAMINED WHICH HAS CONCLUDED THAT DAMAGE TO THE IMPLANT POUCH HAS OCCURRED MOST LIKELY DUE TO THE FINS BREAKING THROUGH THE POUCH, AND AS A RESULT, COMPROMISING THE SECONDARY STERILE BARRIER. AN INCREASE IN COMPLAINTS RECEIVED PROMPTED FURTHER INVESTIGATION AND AS A RESULT, A HHED WAS INITIATED TO ASSESS PATIENT RISK. A RISK ASSESSMENT USING PRODUCT SALES VERSES COMPLAINTS HAS BEEN COMPLETED AND HAS CONFIRMED THE RISK HAS NOT BEEN EXCEEDED AND THEREFORE THERE IS NO RISK TO PATIENT SAFETY. A NEW REVISED PACKAGING CONFIGURATION WENT LIVE ON THE 14TH MARCH 2016 TO UPDATE THE PACKAGING OF THE MALLORY SHELL DEVICES. HOWEVER, THE DEVICES RETURNED FOR THIS PRODUCT EVALUATION WERE PACKAGED USING THE OLD CONFIGURATION DUE TO THE MANUFACTURING DATE PRE-DATING THE NEW PACKAGING WHICH WENT LIVE IN MARCH 2016. NO COMPLAINTS FOR DAMAGED PACKAGING HAVE BEEN RECORDED FOR THE NEW PACKAGING CONFIGURATION. IT CAN BE CONCLUDED THAT THE DEVICES RETURNED IN THIS EVALUATION WERE CONFORMING TO PRE-DEFINED PACKAGING SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: MLRY-HD RNGLC SHL 56MM/L24, ITEM 104156, LOT 3388004. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2018-00177.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INNER POUCHES WERE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62145 MLRY-HD RNGLC SHL 48MM/L22 LZO BIOMET UK LTD. N/A 3541094

    Patients

    Seq Age Sex Outcome Treatment
    1