BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP SCREW, ÿ 4X34MM

    MDR report key: 18778344 · Received February 26, 2024

    Report

    Report Number
    0009613350-2024-00033
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505414
    PMA / PMN Number
    K200814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PRODUCTS AND ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2024-00034-1

    Additional Manufacturer Narrative · 0

    (B)(4). D10. BLUNT TIP SCREW, ÿ 4X36MM ITEM#47248603640 LOT#3091446, BLUNT TIP SCREW, ÿ 4X38MM ITEM#47248603840 LOT#3169760, CORTICAL BONE SCREW, ÿ 4X24MM ITEM#47248612440 LOT#3174997, CORTICAL BONE SCREW, ÿ 4X26MM ITEM#47248612440 LOT#3164766, WASHER SMALL ITEM#47248800004 LOT#3087027, PROXIMAL HUMERUS NAIL CAP, 0MM ITEM#47248801000 LOT#3081964. G2. REPORT SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2024-00034.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL APPROXIMATELY 4 MONTHS AGO. AFTER 2 MONTHS FROM THE INITIAL, SURGEON FOUND ONE OF THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, BUT NO REVISION HAS BEEN PLANNED SO FAR. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298579 BLUNT TIP SCREW, ÿ 4X34MM PROSTHESIS, HIP HSB ZIMMER GMBH N/A 3091296 00889024505414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10 NARRATIVE.