BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-DIAL MODULAR HUMERAL HEADS TRIAL 46MM X 21MM X 50MM

    MDR report key: 6039819 · Received October 19, 2016

    Report

    Report Number
    0001825034-2016-04161
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    June 7, 2016
    Report Date
    March 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWT
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS CONDUCTED ON THE REPORTED ISSUE, AND THE ROOT CAUSE WAS UPDATED ACCORDINGLY. FURTHER EVALUATION RELAYED THAT THIS ISSUE IS DETERMINED TO BE A DESIGN RELATED ISSUE. THE PARTS WERE DETERMINED TO BE MANUFACTURED NON-CONFORMING. A DESIGN CHANGE HAS BEEN INITIATED TO ADDRESS THE REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. EXAMINATION OF THE TRIAL CONFIRMS THE REPORTED CONDITION, AS FOREIGN MATERIAL ON THE DEVICE TESTED POSITIVE FOR HEMOGLOBIN. USER FACILITY'S STERILIZATION TECHNIQUE WAS REVIEWED AND CONFIRMED TO BE CONFORMING TO MANUFACTURER INSTRUCTION. IT IS LIKELY THAT THERE WAS AN IMPROPER CLEANING TECHNIQUE USED AT SOME POINT DURING THE TRIAL'S 4 YEARS OF USE; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CLEANING AND DECONTAMINATION, NUMBER 2 STATES, "DISASSEMBLY-THE MAJORITY OF SURGICAL INSTRUMENTS AND TRIAL PROSTHESES ARE CONSTRUCTED IN SUCH A WAY THAT THEY WILL NOT REQUIRE DISASSEMBLY. HOWEVER, SOME OF THE MORE COMPLEX INSTRUMENTS ARE MADE OF SEVERAL COMPONENTS AND THESE SHOULD BE DISASSEMBLED INTO THEIR INDIVIDUAL PARTS PRIOR TO DECONTAMINATION. IN MOST CASES THE METHOD OF DISASSEMBLY IS SELF-EVIDENT. LOOSEN AND/OR DISASSEMBLE INSTRUMENTS WITH REMOVABLE PARTS. SCREWS OR BOLTS ON SOME INSTRUMENTS CAN BE LOOSENED FOR CLEANING BUT ARE SELF-RETAINING TO PREVENT LOSS. PARTICULAR ATTENTION SHOULD BE TAKEN TO REMOVE ALL DEBRIS FROM ALL CANNULATIONS, CREVICES, SERRATIONS, AND OBSCURE HOLES IN THE INSTRUMENTS." NUMBER 3 STATES, "WASHING/DISINFECTING- IT IS RECOMMENDED THAT THE INSTRUMENTS, DISASSEMBLED AS REQUIRED, BE DECONTAMINATED USING AN AUTOMATIC WASHER-DISINFECTION UNIT UTILIZING THERMAL DISINFECTION. THIS SHOULD PREFERABLY BE OF THE ULTRASONIC OR CONTINUOUS TUNNEL PROCESS TYPE." THIS REPORT IS NUMBER 7 OF 10 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04155 - 04164).

    Description of Event or Problem · 1

    DURING STERILIZATION, BLOOD CONTAMINATE WAS NOTED ON DISASSEMBLED PARTS OF THE TRIAL HEAD. THERE WAS NO PATIENT INJURY OR DELAY IN A PROCEDURE AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692116 VERSA-DIAL MODULAR HUMERAL HEADS TRIAL 46MM X 21MM X 50MM TEMPLATE HWT BIOMET ORTHOPEDICS N/A ZB120702

    Patients

    Seq Age Sex Outcome Treatment
    1