BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TOFFEE HAMMER

    MDR report key: 9144092 · Received October 2, 2019

    Report

    Report Number
    3002806535-2019-00778
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 24, 2019
    Report Date
    April 30, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    UDI-DI
    00880304525658
    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 SURGERY THE OXF UNI TOFFEE HAMMER BROKE. THE HAMMER BROKE AT THE HANDLE DUE TO NORMAL USE. THE SURGERY WAS FINISHED WITH ANOTHER HAMMER. THE BROKEN HAMMER WAS USED ABOUT 20 TIMES. THE INCIDENT HAD NO EFFECT ON THE OPERATION SINCE THE HAMMER HAS FALLEN APART COMPLETELY AT THE TABLE. 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 8 MONTHS. HHED-2019-00636, HHE2019-00339 AND CAPA CA-04950 WERE INITIATED TO ADDRESS THE ISSUE THAT WELDING PROCESSES ARE 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 REPORTS NO DEVIATIONS IDENTIFIED. THE ITEM IS COVERED BY CAPA, CA-04950 THAT INVESTIGATES VALIDATION OF THE WELDING PROCESS. 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. RISK ASSESSMENT: A REVIEW OF THE COMPLAINT DATABASE HAS FOUND ONE SIMILAR COMPLAINT REPORTED WITH THIS ITEM # / LOT # COMBINATION. A REVIEW OF THE COMPLAINTS DATABASE FOR 3 YEARS PRIOR TO THE NOTIFICATION DATE HAS FOUND 6 SIMILAR REPORTED EVENTS, EXCLUDING THIS EVENT, FOR ITEM NUMBER 32-422760. THE FAILURE IS CAPTURED WITHIN CAPA CA-04950. RISK MANAGEMENT REPORT OXF CEMENTED RMR UKF0280 SKN002 REV 04 AND OXF CEMENTED INSTRUMENTS I_O UKF0591 SKN002B REV 6 DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. LINE 4.1.2.3 OF RISK FILE OXF CEMENTED INSTRUMENTS I_O UKF0591 SKN002B REV 6 RELATES TO THE REPORTED EVENT: IMPROPER RAW MATERIALS: THE INSTRUMENT DOES NOT WITHSTAND MECHANICAL FORCES. THIS LINE HAS A MAXIMUM SEVERITY SCORE OF 2: MINOR WHICH IS DEFINED IN THE APPLICABLE UKP003 AS: ILLNESS OR INJURY THAT DOES NOT REQUIRE PRESCRIBED MEDICAL OR SURGICAL INTERVENTIONS. THE REPORTED EVENT STATES THAT DURING SURGERY THE OXF UNI TOFFEE HAMMER BROKE. THE HAMMER BROKE AT THE HANDLE DUE TO NORMAL USE. THE SURGERY WAS FINISHED WITH ANOTHER HAMMER. THE BROKEN HAMMER WAS USED ABOUT 20 TIMES. THE INCIDENT HAD NO EFFECT ON THE OPERATION SINCE THE HAMMER HAS FALLEN APART COMPLETELY AT THE TABLE. THE EVENT HAS BEEN ASSESSED FOR THE SEVERITY OF HARM. NO HARM HAS BEEN REPORTED TO THE PATIENT OR HEALTH CARE PROFESSIONAL, THEREFORE, THIS GIVES A SEVERITY LEVEL OF 1: NEGLIGIBLE AS PER APPLICABLE UKP003. THE OUTCOME OF THIS COMPLAINT IS WITHIN THE SEVERITY OF THE RMR. CONCLUSION: THE REPORTED EVENT IS CONFIRMED. THE 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 PROCESSES ARE NOT VALIDATED IN JINHUA, CHINA.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HOSPITAL THAT DURING SURGERY, OXF UNI TOFFEE HAMMER BROKE DUE TO NORMAL USE. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH ANOTHER HAMMER. IT'S ALSO REPORTED THAT THE HAMMER WAS USED APPROXIMATELY 20 TIMES.

    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 IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT DURING SURGERY, OXF UNI TOFFEE HAMMER BROKE DUE TO NORMAL USE. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH ANOTHER HAMMER. IT'S ALSO REPORTED THAT THE HAMMER WAS USED APPROXIMATELY 20 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939743 OXF UNI TOFFEE HAMMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB170702 00880304525658

    Patients

    Seq Age Sex Outcome Treatment
    1