BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD UNI TWIN-PEG FEMORAL SM

    MDR report key: 9574299 · Received January 10, 2020

    Report

    Report Number
    3002806535-2020-00014
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 12, 2019
    Report Date
    April 16, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P01004
    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. THE PRODUCTS WAS RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION ENGINEER FOR INVESTIGATION. THE EVENT REPORTS THAT IT WAS IDENTIFIED THAT THE TOP FOAM HAS ADHERED TO THE TYVEK LID. THIS EVENT OCCURRED DURING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED. NO HARM WAS REPORTED. THE COMPLAINT HAS BEEN CONFIRMED FOLLOWING REVIEW OF THE RETURNED PACKAGING, WHICH CONFIRMED THE FOAM HAS ADHERED TO THE TYVEK LID. 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 11 SIMILAR COMPLAINTS FOR THE SAME ITEM NUMBER. A COMPLAINT HISTORY REVIEW IDENTIFIED NO SIMILAR COMPLAINTS FOR THE SAME LOT NUMBER. THE REPORTED EVENT IS COVERED BY INST 4.4.1.9 INPUT OUTPUT RISK TABLE ¿ STERILE DEVICE PACKAGING, REVISION 03. THE SEVERITY OF THE REPORTED EVENT AND THE CALCULATED OCCURRENCE FOR ALL SIMILAR EVENTS IN THE LAST 3 YEARS ARE IN LINE WITH THIS RISK FILE. THE OVERALL RISK SCORE IS NEGLIGIBLE. THIS DEVICE IS USED FOR TREATMENT. THE REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. THE IFU PROVIDED WITH THE DEVICE STATES TO CHECK THE PACKAGING FOR DAMAGE BEFORE USE. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE CORRECT PACKAGING MATERIALS AND SEALING METHODS HAVE BEEN USED. THE LIKELY CAUSE OF THE REPORTED EVENT IS NOT ENOUGH CLEARANCE BETWEEN THE TOP FOAM AND THE TYVEK LID DURING THE HEAT SEALING PROCESS. THIS CAUSES UNINTENDED HEAT TRANSFERS BETWEEN THE TOP FOAM AND THE TYVEK LID, RESULTING IN ADHESION. THE INDENT IN THE TOP FOAM (WHICH HAVE BEEN CAUSED BY COMPRESSION FROM THE DEVICE) FURTHER INDICATE THAT THE SPACE WITHIN THE BLISTER WOULD HAVE BEEN LIMITED. ISSUE EVALUATION (B)(4) HAS BEEN RAISED TO FURTHER INVESTIGATE THIS ISSUE. HEALTH HAZARD EVALUATION (B)(4) HAS BEEN RAISED TO ASSESS THE RISK OF PRODUCT WHICH MAY EXHIBIT THE ISSUE IN THE FIELD. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOAM IN THE STERILE PACKAGING STUCK TO THE STERILE LID. SUBSEQUENTLY, THE HOSPITAL CONSIDERED THE IMPLANT TO BE NON-STERILE.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN 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 WAS REPORTED THAT THE FOAM IN THE STERILE PACKAGING STUCK TO THE STERILE LID. SUBSEQUENTLY, THE HOSPITAL CONSIDERED THE IMPLANT TO BE NON-STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38038 OXFORD UNI TWIN-PEG FEMORAL SM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT NRA BIOMET UK LTD. N/A J6605411

    Patients

    Seq Age Sex Outcome Treatment
    1