BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF FEM TRIAL REMOVER VER

    MDR report key: 9063932 · Received September 15, 2019

    Report

    Report Number
    3002806535-2019-00751
    Event Type
    Malfunction
    Date Received
    September 15, 2019
    Date of Event
    September 9, 2019
    Report Date
    May 5, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN CANADA. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. IT WAS REPORTED THAT DURING SURGERY, THE SLAP HAMMER MECHANISM BROKE. THE CLAWS WERE NO LONGER WORKING WHICH MADE THE INSTRUMENT UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE INSTRUMENT ALSO SHOWS SIGNS OF GENERAL WEAR AND TEAR FROM USE. WITH THE EXCEPTION OF THE SPRING, WHICH IS THE REPORTED EVENT, THE REST OF THE INSTRUMENT ASSEMBLY LOOKS AND FUNCTIONS AS PER THE DRAWING AND DESIGN SPECIFICATION. THE SLAP HAMMER HAS BEEN IN THE FIELD FOR APPROXIMATELY 19 YEARS. THE SLAP HAMMER WAS MANUFACTURED BY EUROCUT SOMETIME IN 2001 (INDICATED BY THE START OF THE LOT # BEING E1). A MEMO FROM ORCHID ORTHOPEDIC SOLUTIONS SHEFFIELD LTD CONFIRMS THAT MANUFACTURING RECORDS FROM EUROCUT ARE NOT AVAILABLE PRE MAY 2008. WITHOUT THE OPPORTUNITY TO REVIEW MANUFACTURING RECORDS THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL CANNOT BE DETERMINED. COMPLAINTS CONTINUE TO BE MONITORED THROUGH TRENDING AND PMS REVIEWS. THE HARM SEVERITY SCORE IS WITHIN LIMITS AS PER THE RMR. THE OCCURRENCE RATE IS ALSO WITHIN THE LIMITS OF THE RMR. THE UNDERLYING CAUSES OF THE PROBLEM IS LIKELY TO BE GENERAL WEAR AND TEAR. A REVIEW OF THE COMPLAINT DATABASE FOR THE ITEM # / LOT # COMBINATION HAS FOUND NO SIMILAR REPORTED COMPLAINTS. A REVIEW OF THE COMPLAINTS DATABASE FOR 3 YEARS PRIOR TO THE NOTIFICATION DATE AND UP TO AND INCLUDING 28 APRIL 2020 HAS FOUND FIVE SIMILAR REPORTED COMPLAINTS FOR ITEM NUMBER 32-420126 (INCLUDING THIS COMPLAINT). RISK ASSESSMENT: RISK MANAGEMENT REPORT OXF CEMENTED DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. LINE 4.2.1.4 OF RISK FILE OXF CEMENTED INSTRUMENTS RELATES TO THE REPORTED EVENT: IMPROPER DESIGN: MECHANICAL INCOMPATIBILITY BETWEEN INSTRUMENTS 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 SLAP HAMMER MECHANISM BROKE. THE CLAWS WERE NO LONGER WORKING WHICH MADE THE INSTRUMENT UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT. THE REPORTED EVENT HAS BEEN ASSESSED FOR SEVERITY OF HARM. NO HARM HAS BEEN REPORTED TO A PATIENT OR HEALTH CARE PROFESSIONAL AND A DELAY OF LESS THAN 5 MINUTES OCCURRED, THEREFORE, THIS GIVES A SEVERITY LEVEL OF 1-NEGLIGIBLE AS PER APPLICABLE UKP003. THE HARM SEVERITY SCORE IS WITHIN LIMITS AS PER THE RMR. SALES DATA FOR ALL FEMURS SOLD FOR THE 3 YEAR PERIOD ¿ 239,342. THIS GIVES AN OCCURRENCE OF (B)(4). THE OCCURRENCE RATE IS WITHIN THE LIMITS OF THE RMR. CORRECTIVE ACTION TAKEN: IE-10329 WAS RAISED DURING PREVIOUS INVESTIGATIONS FOR SIMILAR REPORTED EVENTS. THE IE CONCLUDED THAT: THE SPRING USED IN THESE SLAPHAMMER ASSEMBLIES IS REQUIRED TO PROVIDE A PRE-LOAD, IN ORDER THAT THE INSTRUMENTS AND TRIALS ARE SECURELY HELD WHEN THE SLAPHAMMER IS USED. IT IS THEREFORE NECESSARY TO USE A SPRING THAT IS HELD IN TENSION WHEN THE INSTRUMENT JAWS ARE CLOSED. THE WORKING LENGTH OF THE SPRING, PROVIDED BY THE MANUFACTURER, IS FOR GUIDANCE ONLY AND DOES NOT IMPLY A HARD LIMIT NOR DEFINE THAT THE SPRING CANNOT BE SAFELY USED OUTSIDE THESE PARAMETERS. IE-05858 WAS PREVIOUSLY OPENED TO REVIEW SPRING FAILURES RELATING TO THIS INSTRUMENT, AND CAME TO THE CONCLUSION THAT THE OCCURRENCE RATE AND SEVERITY OF HARM WAS WITHIN THE VALUES SPECIFIED BY THE RELEVANT RISK MANAGEMENT DOCUMENTATION. REVIEW OF THE OCCURRENCE AND SEVERITY FOR THE PRESENT IE SHOWS THAT THE OCCURRENCE AND SEVERITY REMAIN WITHIN THE RISK MANAGEMENT LEVELS. NO INFORMATION IS PRESENTED IN THE CURRENT IE THAT WOULD ALTER THE CONCLUSIONS OF THE PREVIOUS IE. THE MANUFACTURER RECOMMENDED WORKING RANGE FOR THE SPRING DOES NOT DEFINE ITS LIMITS. PREVENTIVE ACTION TAKEN IE-10329 WAS RAISED DURING PREVIOUS INVESTIGATIONS FOR SIMILAR REPORTED EVENTS. THE IE CONCLUDED THAT: THE SPRING USED IN THESE SLAPHAMMER ASSEMBLIES IS REQUIRED TO PROVIDE A PRE-LOAD, IN ORDER THAT THE INSTRUMENTS AND TRIALS ARE SECURELY HELD WHEN THE SLAPHAMMER IS USED. IT IS THEREFORE NECESSARY TO USE A SPRING THAT IS HELD IN TENSION WHEN THE INSTRUMENT JAWS ARE CLOSED. THE WORKING LENGTH OF THE SPRING, PROVIDED BY THE MANUFACTURER, IS FOR GUIDANCE ONLY AND DOES NOT IMPLY A HARD LIMIT NOR DEFINE THAT THE SPRING CANNOT BE SAFELY USED OUTSIDE THESE PARAMETERS. IE-05858 WAS PREVIOUSLY OPENED TO REVIEW SPRING FAILURES RELATING TO THIS INSTRUMENT, AND CAME TO THE CONCLUSION THAT THE OCCURRENCE RATE AND SEVERITY OF HARM WAS WITHIN THE VALUES SPECIFIED BY THE RELEVANT RISK MANAGEMENT DOCUMENTATION. REVIEW OF THE OCCURRENCE AND SEVERITY FOR THE PRESENT IE SHOWS THAT THE OCCURRENCE AND SEVERITY REMAIN WITHIN THE RISK MANAGEMENT LEVELS. NO INFORMATION IS PRESENTED IN THE CURRENT IE THAT WOULD ALTER THE CONCLUSIONS OF THE PREVIOUS IE. THE MANUFACTURER RECOMMENDED WORKING RANGE FOR THE SPRING DOES NOT DEFINE ITS LIMITS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE SLAPHAMMER MECHANISM BROKE AND THE CLAWS WERE NO LONGER WORKING WHICH MADE THE INSTRUMENT UNUSABLE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE SLAPHAMMER MECHANISM BROKE AND THE CLAWS WERE NO LONGER WORKING WHICH MADE THE INSTRUMENT UNUSABLE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT. DELAY: LESS THAN 5 MINUTES. HARM: NO PATIENT, USER, OR OTHER STAKEHOLDER HARM.

    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 THAT DURING SURGERY, THE SLAPHAMMER MECHANISM BROKE AND THE CLAWS WERE NO LONGER WORKING WHICH MADE THE INSTRUMENT UNUSABLE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING ANOTHER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859821 OXF FEM TRIAL REMOVER VER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A E1 14997

    Patients

    Seq Age Sex Outcome Treatment
    1