BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF KNEE PH3 I/M ROD RMVL HK L HK

    MDR report key: 9896817 · Received March 30, 2020

    Report

    Report Number
    3002806535-2020-00185
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 2, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWT
    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 FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, G7, H1, H2, H3, H6, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN GERMANY. A: PATIENT INFORMATION NOT PROVIDED DUE TO DATA PROTECTION. PRODUCT HAS BEEN RECEIVED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MIR REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN GERMANY. SUMMARY: THE PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE PRODUCT EVALUATION COMPLAINTS ENGINEER FOR INVESTIGATION. THE EVENT REPORTS THAT THE INSTRUMENT HAS FRACTURED. THIS EVENT OCCURRED DURING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THE COMPLAINT HAS BEEN CONFIRMED FOLLOWING REVIEW OF THE RETURNED INSTRUMENT, WHICH CONFIRMED THE INSTRUMENT IS FRACTURED. VISUAL EXAMINATION CONFIRMS THE LARGE PIN HAS FRACTURED FORM THE MAIN BODY OF THE INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW IDENTIFIED 8 SIMILAR COMPLAINTS FOR THE SAME ITEM NUMBER, OF WHICH 5 WERE RECEIVED IN THE LAST 3 YEARS (INCLUDING (B)(4)). A COMPLAINT HISTORY REVIEW IDENTIFIED 0 SIMILAR COMPLAINTS FOR THE SAME ITEM/LOT COMBINATION. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED EVENT IS NOT RELATED TO A COMBINATION OF IMPLANTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. THE REUSABLE INSTRUMENT LIFESPAN MANUAL INSTRUCTS TO LOOK FOR FRACTURES AND SURFACE DAMAGE DURING REPROCESSING. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE LIKELY ROOT CAUSE OF THE REPORTED EVENT IS THE INSTRUMENT HAS SURPASSED ITS REUSABLE LIFE (AGED). THE INSTRUMENT HAD BEEN IN THE FIELD FOR OVER 5 YEARS BEFORE THE REPORTED EVENT. DURING THIS TIME THE INSTRUMENT IS LIKELY TO HAVE BEEN SUBJECT TO MULTIPLE USES, AND MULTIPLE DECONTAMINATION AND STERILISATION CYCLES (WHICH INCLUDE CHEMICALS AND HIGH TEMPERATURES). THIS WOULD HAVE CAUSED THE INSTRUMENT TO WEAR OVER TIME. RISK ASSESSMENT: SEVERITY ASSESSMENT: THIS EVENT OCCURRED DURING SURGERY. THIS GIVES A SEVERITY SCORE OF 2. THE ACTUAL SEVERITY SCORE IS IN LINE WITH THE RISK FILE. OCCURRENCE ASSESSMENT: SALES DATA SCOPE DATE: JULY 2017 TO JUN 2020 (MOST UP TO DATE SALES DATA). ITEM NUMBERS: ALL IMPLANTS COMPATIBLE WITH INSTRUMENT 32-401111. NUMBER OF ITEMS SOLD: (B)(4). COMPLAINT HISTORY SEARCH CRITERIA: DATE: 01 JULY 2017 TO AUG 2020 (DATE SEARCH WAS CONDUCTED), ITEM NUMBER ¿ 32-401111, FILTERS ¿ ALL COMPLAINT CATEGORIES RELATING TO DAMAGE TO THE BLACK END OF THE IMPACTOR. NUMBER OF COMPLAINTS IDENTIFIED: 5 (INCLUDING (B)(4)). OCCURRENCE RATIO 5:269,591 = 1:53,918. RISK SCORE : S2 X O2 ¿ RPN 4 (LOW). RISK ASSESSMENT SUMMARY: THE SEVERITY OF THE REPORTED EVENT IS IN LINE WITH THIS RISK FILE. THE OCCURRENCE RATE FOR ALL SIMILAR EVENTS IS ALSO IN LINE WITH THE RISK FILE. THE RPN IS LOW RISK. NO CORRECTIVE ACTION REQUIRED AT THIS TIME. BOTH THE SEVERITY AND OCCURRENCE OF THE REPORTED EVENT ARE IN LINE WITH THE RISK FILE. NO HARM BEYOND EXTENSION TO SURGERY TIME, MINOR, HAS BEEN REPORTED. THE ITEM WAS DISTRIBUTED CONFORMING. THE INSTRUMENT HAS LIKELY PASSED ITS REUSABLE LIFESPAN, WHICH IS WELL DOCUMENTED IN THE REUSABLE INSTRUMENT LIFESPAN MANUAL. 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 THE INSTRUMENT FRACTURED (PIN ON THE HANDLE). THERE WAS NO DELAY OF THE PROCEDURE. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER. ADDITIONAL INFORMATION: THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MIR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED (PIN ON THE HANDLE). THERE WAS NO DELAY OF THE PROCEDURE. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER. ADDITIONAL INFORMATION: THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. PRODUCT INVESTIGATION COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). PMA/510(K): EXEMPT. 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 THE PIN ON THE HANDLE BROKE. NO DELAY WAS REPORTED. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359868 OXF KNEE PH3 I/M ROD RMVL HK L HK ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR HWT BIOMET UK LTD. N/A ZB140901

    Patients

    Seq Age Sex Outcome Treatment
    1