BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TOFFEE HAMMER

    MDR report key: 9568233 · Received January 9, 2020

    Report

    Report Number
    3002806535-2020-00012
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 10, 2019
    Report Date
    April 22, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    FZY
    UDI-DI
    00088030452658
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. RESULTS OF PRODUCT EVALUATION: THE REPORTED EVENT STATES THAT DURING THE PROCEDURE WHEN HAMMERING A TRIAL FEMUR THE HAMMER BROKE. NO PATIENT INJURY OR DELAY IN THE PROCEDURE. THE SURGERY WAS COMPLETED USING ANOTHER INSTRUMENT. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT, THE WELD FAILED AT THE POINT WHERE THE SHAFT MEETS THE HANDLE DUE TO LACK OF FUSION OF THE WELD JOINT. THE PRODUCT WAS IN THE FIELD FOR APPROXIMATELY 2 YEARS AND 3 MONTHS. CAPA CA-04950 WAS INITIATED TO ADDRESS THE ISSUE THAT WELDING PROCESS IS NOT VALIDATED IN JINHUA, CHINA. THE REPORTED ITEM IN THIS COMPLAINT, 32-422760, IS INCLUDED IN THE SCOPE OF THE CAPA. THEREFORE, NO FURTHER INVESTIGATION WILL BE CARRIED OUT. RESULTS OF DEVICE HISTORY RECORD REVIEW: THE DHR REVIEW FROM THE MANUFACTURING SITE SHOWS THAT AN (B)(4) WAS ISSUED FOR WELDING DISCOLORATION ISSUE AND WAS ACCEPTED AFTER ENGINEERING REVIEW. THE BATCH PART IS CONFORMING BEFORE FINAL RELEASE FROM MANUFACTURING SITE, NO DEVIATIONS ARE RELATED TO THE REPORTED EVENT. IFU AND/OR SURGICAL PROCEDURE REFERENCE: REPROCESSING INSTRUCTIONS: REUSABLE SURGICAL INSTRUMENTS CAT, NO. 5401000246 VERSION 2.3 (MARCH 2009). THE INSTRUCTIONS FOR REUSABLE SURGICAL INSTRUMENTS WARNS THAT: ALL INSTRUMENTS SHOULD BE VISUALLY CHECKED FOR DAMAGE AND WEAR. CONCLUSION: THE REPORTED EVENT IS CONFIRMED. ROOT CAUSE IS DETERMINED TO BE THE WELD FAILURE, AT THE POINT WHERE THE SHAFT MEETS THE HANDLE, DUE TO LACK OF FUSION OF THE WELD JOINT. CAPA CA-04950 WAS INITIATED TO ADDRESS THE ISSUE THAT WELDING PROCESS IS NOT VALIDATED IN JINHUA, CHINA. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT DURING A PARTIAL KNEE PROCEDURE A TOFFEE HAMMER FRACTURED. NO PATIENT INJURY OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN-EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 HAS BEEN REPORTED THAT DURING A PARTIAL KNEE PROCEDURE A TOFFEE HAMMER FRACTURED. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35964 OXF UNI TOFFEE HAMMER KNEE INSTRUMENTS FZY BIOMET UK LTD. N/A ZB180101 00088030452658

    Patients

    Seq Age Sex Outcome Treatment
    1