BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF KNEE PH3 I/M ROD RMVL HK

    MDR report key: 11973190 · Received June 10, 2021

    Report

    Report Number
    3002806535-2021-00249
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HXC
    UDI-DI
    05019279469246
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SUMMARY: THE COMPLAINT STATES, IT WAS REPORTED THAT DURING SURGERY THE HOOK OF INSTRUMENT BROKE OFF WHEN SURGEON WENT TO PULL THE ROD OUT OF THE FEMUR. THE PART WAS FOUND. NO PATIENT HARM AND NO SURGICAL DELAY. THIS EVENT OCCURRED DURING SURGERY. NO HEALTH CONSEQUENCES OR IMPACT. REVIEW OF RETURNED PRODUCT CONFIRMS THAT THE INSTRUMENT (D32-401111 REV K OXF KNEE PH3 IM ROD RMVL HK) IS DAMAGED AND THAT THE LARGE PIN (D32-401111-2 REV G OXF KNEE PH3 IM ROD RMVL HK LARGE PIN) IS MISSING. VISUAL INSPECTION OF THE REPORTED EVENT CONFIRMS THAT THE REMOVAL HOOK IS DAMAGED AND THAT THE LARGE PIN (D32-401111-2 REV G OXF KNEE PH3 IM ROD RMVL HK LARGE PIN) HAS FRACTURED. THE INSTRUMENT SHOW SIGNS OF WEAR AND TEAR WHICH IS IN LINE WITH REPEATED USE AND TIME IN FIELD (APPROXIMATELY 15 YEARS AND 2 MONTHS). DIMENSIONAL CHECK WAS NOT CARRIED OUT AS DIMENSIONAL NON-CONFORMANCE DOES NOT HAVE ANY IMPACT ON THE REPORTED EVENT. NO ASSEMBLY CHECKS WERE CARRIED OUT AS PRODUCT IS NOT PART OF AN ASSEMBLY AND THE FRACTURED COMPONENT WAS NOT RETURNED. AS THE INSTRUMENT HAS BEEN OPERATIONAL IN THE FIELD FOR AN EXTENDED PERIOD IT IS DEEMED TO HAVE BEEN FUNCTIONAL AND WITHOUT ANY NON-CONFORMANCE BEFORE FAILURE. THE ROOT CAUSE CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION HOWEVER, THE LIKELY ROOT CAUSE OF THE REPORTED EVENT IS END OF USEABLE LIFESPAN AFTER HAVING BEEN IN THE FIELD FOR APPROXIMATELY 15 YEARS AND 2 MONTHS. THE CONTROLS OUTLINED WITHIN THE REUSABLE INSTRUMENT LIFESPAN MANUAL INFORMS THE USER OF THE FOLLOWING INSPECTION AND TESTING INSTRUCTIONS TO ENSURE THE CONDITION OF THE INSTRUMENTS ARE REGULARLY MONITORED AND ASSESSED DURING THE REPROCESSING OPERATION: INSPECTION/FUNCTION TESTING WHILE LOADING INSTRUMENTS INTO THEIR RESPECTIVE INSTRUMENT CASES AFTER CLEANING AND PRIOR TO STERILIZATION, REFERENCE THE MANUAL AND FOLLOW THE INSTRUCTIONS BELOW. 1. INSTRUMENTS SHOULD BE INSPECTED FOR COMPLETENESS AND FUNCTION. 2. INSPECTION INCLUDES: A. CHECKING INSTRUMENTS THAT FORM PART OF A LARGER ASSEMBLY OR ASSEMBLE WITH MATING COMPONENTS. B. CHECKING INTERNAL MECHANISMS SUCH AS O-RINGS, SPRINGS, AND SUBCOMPONENTS, IF THE DEVICE IS INTENDED TO BE DISASSEMBLED FOR PROPER REPROCESSING. C. ACTUATING MOVING PARTS SUCH AS HINGES/JOINTS AND MOVEABLE FEATURES SUCH AS HANDLES, RATCHETING, COUPLINGS, AND SLIDING PARTS. D. INSPECTING FOR ALL FORMS OF WEAR OUTLINED IN THIS MANUAL. 3. RESULTS OF ASSEMBLY, ACTUATION, AND EXTENT OF ALL FORMS OF WEAR SHOULD BE CONSIDERED IN DETERMINING WHETHER AN INSTRUMENT IS SUITABLE FOR USE. 4. IF THE REUSABLE INSTRUMENT IS DETERMINED NO LONGER SUITABLE FOR USE OR IF THE SUITABILITY FOR USE IS STILL IN QUESTION AFTER INSPECTING THE INSTRUMENT AND REFERENCING THE REUSABLE INSTRUMENT LIFESPAN MANUAL, INITIATE THE PROCESS TO RETURN THE INSTRUMENT(S) TO THE MANUFACTURER. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED. A REVIEW OF THE MANUFACTURING HISTORY RECORD (DHR ITEM 32-401111 LOT 336790) CONFIRMS THAT ALL OPERATIONS AND REQUIRED INSPECTIONS WERE CARRIED OUT AS PER SPECIFICATION AND SUGGESTS THAT THE PRODUCT LEFT ZB CONFORMING TO SPECIFICATION. REVIEW OF THE MANUFACTURING HISTORY RECORD (DHR ITEM 32-401111 LOT 336790) DOES NOT SHOW ANY HISTORY OF ANY NON-CONFORMANCES DURING THE MANUFACTURE OF THE PRODUCT. AS THE INSTRUMENT HAS BEEN OPERATIONAL IN THE FIELD FOR AN EXTENDED PERIOD IT IS DEEMED THAT THE MATERIAL WAS CONFORMING TO SPECIFICATION ON FINAL RELEASE FROM THE ZB MANUFACTURING SITE AND WITHOUT ANY NON-CONFORMANCE BEFORE FAILURE. STERILE CERTIFICATE REVIEW IS NOT REQUIRED AS THE INSTRUMENT WAS SUPPLIED AS UNSTERILIZED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS DID NOT SHOW ANY CAPA OR HHED ASSOCIATED TO THIS COMPLAINT CATEGORY. BOTH THE SEVERITY AND OCCURRENCE OF THE REPORTED EVENT ARE IN LINE WITH THE RISK FILE. NO HARM TO PATIENT HAS BEEN REPORTED. THE ITEM WAS DISTRIBUTED CONFORMING. ADEQUATE INSTRUCTIONS ARE PROVIDED TO ENSURE THE INSTRUMENT IS REPROCESSED CORRECTLY. THE HAZARD AND REPORTED HARM ARE COVERED BY THE RISK FILE AND THE SEVERITY/OCCURRENCE AND THE RISK SCORES ARE WITHIN ACCEPTABLE LIMITS. THE OVERALL RISK IS CONSIDERED TO BE LOW. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE HOOK OF INSTRUMENT BROKE OFF WHEN SURGEON WENT TO PULL THE ROD OUT OF THE FEMUR.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 DURING SURGERY THE HOOK OF INSTRUMENT BROKE OFF WHEN SURGEON WENT TO PULL THE ROD OUT OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875537 OXF KNEE PH3 I/M ROD RMVL HK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXC BIOMET UK LTD. N/A 336790 05019279469246

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR