BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFN LAG SCREW 10.5MM X 80MM

    MDR report key: 14222446 · Received April 27, 2022

    Report

    Report Number
    0001825034-2022-00954
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 6, 2022
    Report Date
    July 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868038983
    PMA / PMN Number
    K100238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM, CAT: 814510080 LOT: YG1121280B HFN LAG SCREW 10.5MM X 80MM. SOURCE: FOREIGN- (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 FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND BUBBLES IN THE POUCH SEAL. SEAL TESTS WERE PERFORMED IN WHICH ALL RESULTS ARE WITHIN THE ACCEPTABLE LIMITS. THE PRODUCT WAS FOUND TO BE CONFORMING. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. FURTHER, THE EVENT DID NOT CONTRIBUTE TO A SERIOUS INJURY; THEREFORE, THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN CONFIRMED THAT THE PRODUCT WAS FOUND TO BE CONFORMING THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635570 HFN LAG SCREW 10.5MM X 80MM SCREW, FIXATION HSB ZIMMER BIOMET, INC. 8145-10-080 YG1121280B 00887868038983

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown