BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGC V2 INTERLOK TIB 8 X 63MM

    MDR report key: 7215636 · Received January 24, 2018

    Report

    Report Number
    3002806535-2018-00156
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    November 3, 2017
    Report Date
    August 8, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE PRODUCT EVALUATION COMPLAINTS ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS: THE RETURNED ¿AGC V2 INTERLOK TIB 8 X 63MM¿ DEVICE AND PACKAGING WAS RETURNED FOR EVALUATION WITH THE FOLLOWING OBSERVATIONS:- THE COMPLETE PACKAGING INCLUDING THE BLISTER HAD DAMAGE FROM COMING INTO CONTACT WITH FLUIDS. THE TOP FOAM WAS NOT RETURNED WITH THE PACKAGING. THE CARDBOARD CARTON HAD PUNCTURE HOLES AND FAYED EDGES FROM POSSIBLE IMPROPER HANDLING AND TRANSPORTATION. DOCUMENTATION REVIEW: THE MANUFACTURING RECORDS HAVE BEEN CHECKED FOR MANUFACTURING REVIEW, REWORK AND SCRAP ACTIVITIES. WITH THE FOLLOWING OBSERVATIONS:- MHR ¿ 3168963 6 DEVICES ON MANUFACTURING RUN. 6 DEVICE PACKAGED AND DISTRIBUTED. NO DEVIATIONS REWORK OR SCRAP GENERATED. BILL OF MATERIALS REVIEW: - THE ¿BILL OF MATERIALS¿ ON SAP HAS BEEN CHECKED AGAINST THE MANUFACTURING HISTORY RECORD WITH NO DEVIATIONS FOUND. COMPLAINTS: NO FURTHER COMPLAINTS FOUND FOR THIS LOT AND PART NUMBER COMBINATION. 2 COMPLAINTS WERE REPORTED FOR INNER POUCH DAMAGES WITHIN THE AGC V2 TIBIAL DEVICE PRODUCT FAMILY. THE DOCUMENTATION, PACKAGING PROCEDURES AND PROCESS WERE EVALUATED, WITH THE CONCLUSION THAT THE DEVICE AND PACKAGING WERE MOST LIKELY CONFORMING TO PRE-DEFINED SPECIFICATION WHEN MANUFACTURED. NO CORRECTIVE ACTION REQUIRED DUE TO THE DEVICE AND PACKAGING BEING DETERMINED AS CONFORMING TO PRE-DEFINED SPECIFICATION WHEN MANUFACTURED. THE CAUSE OF THE REPORTED EVENT WAS MOST LIKELY DUE TO TRANSPORTATION AND HANDLING OF THE DEVICE DURING DISTRIBUTION BETWEEN HOSPITALS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS NO INNER VACUUM PACKING OF THIS PRODUCT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58093 AGC V2 INTERLOK TIB 8 X 63MM JWH BIOMET UK LTD. N/A 3168963

    Patients

    Seq Age Sex Outcome Treatment
    1