BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X38MM

    MDR report key: 23225526 · Received October 6, 2025

    Report

    Report Number
    0009613350-2025-00754
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K200814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 47249616109, PROXIMAL HUMERUS, LEFT, ÿ 9X160MM, LOT # 3233558. ITEM # 47248604040, ANN BLUNT TIP SCREW 4X40MM, LOT # 3242834. ITEM # 47248604240, ANN BLUNT TIP SCREW 4X42MM, LOT # 3208883. ITEM # 47248605040, ANN BLUNT TIP SCREW 4X50MM, LOT # 3218771. ITEM # 47248612440, ANN CORT BONE SCREW 4 X 24MM, LOT # 3216555. ITEM # 47248612640, ANN CORT BONE SCREW 4 X 26MM, LOT # 3228725. ITEM # 47248613640, ANN CORT BONE SCREW 4 X 36MM, LOT # 3189224. ITEM # 47248801000, AFFIXUS PH NL CAP 0MM, LOT # 3238877. ITEM # 47249616109, ANN PH NAIL LT 9X160MM, LOT # 3233558. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE CORELOCK MECHANISM AS A POTENTIAL CONTRIBUTING FACTOR. HOWEVER, AS FURTHER BIOMECHANICAL TESTING WAS CARRIED OUT, AND THE PERFORMANCE IS IN AN ACCEPTABLE RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES, NO DESIGN CHANGES WERE CONDUCTED. 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 1 MONTH POST-IMPLANTATION, SURGEON FOUND ALL OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342713 ANN BLUNT TIP SCREW 4X38MM TRAUMA, PLATE HSB ZIMMER GMBH 3237314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female