BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL DISPOSABLE INST KIT

    MDR report key: 11067156 · Received December 23, 2020

    Report

    Report Number
    0001825034-2020-04411
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    October 2, 2020
    Report Date
    December 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NAME: KDD. UDI: (B)(4). VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE STERILE PACKAGING IS WARPED. STERILITY HAS BEEN COMPROMISED. COMPLAINT IS CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THESE PRODUCTS WERE LIKELY NON-CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE OPERATOR NOT FOLLOWING INSTRUCTIONS DURING MANUFACTURING. A CORRECTIVE ACTION HAS BEEN INITIATED TO FURTHER ADDRESS THE REPORTED ISSUE. 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 · 1

    IT WAS REPORTED THAT THE CASING OF THE ACL DISPOSABLE KIT WAS WARPED AND THE SURGICAL TECH WAS NOT ABLE TO OPEN. THE SURGICAL TECH PASSED OFF THAT KIT AND WE OPENED A DIFFERENT KIT (SAME ITEM NUMBER), WHICH WORKED FINE. THE FIRST CASING OF ACL KIT IS VISIBLY WARPED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533965 ACL DISPOSABLE INST KIT KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD ZIMMER BIOMET, INC. NI 254970

    Patients

    Seq Age Sex Outcome Treatment
    1