BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN BLUNT TIP SCREW 4X48MM

    MDR report key: 22587001 · Received July 24, 2025

    Report

    Report Number
    0009613350-2025-00624
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505483
    PMA / PMN Number
    K231114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. ANN BLUNT TIP SCREW 4X50MM ITEM# 47248605040 LOT# 3228024. ANN BLUNT TIP SCREW 4X54MM ITEM# 47248605440 LOT# 3157875. ANN PH NAIL RT 9X160MM ITEM# 47249616009 LOT# 3230675. BLUNT TIP SCREW, ÿ 4X65MM ITEM# 47248606540 LOT# 3197006. CORTICAL BONE SCREW, ÿ 4X30MM ITEM# 47248613040 LOT# 3232072. CORTICAL BONE SCREW, ÿ 4X32MM ITEM# 47248613240 LOT# 3220939. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM# 47248801000 LOT# 3234492. 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 WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT (B)(4). 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. AS THE DEVICES INVOLVED IN THE REPORTED EVENT WERE NOT RETURNED FOR INVESTIGATION, A FURTHER PRODUCT EVALUATION COULD NOT BE PERFORMED AND IT IS NOT POSSIBLE TO TEST THE ASSEMBLY OF THE INVOLVED PARTS. IT CAN BE ASSUMED THAT MULTIPLE CONTRIBUTING FACTORS, RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR OR IMPLANTATION PROCEDURE, CONTRIBUTED TO THE MIGRATION OF THE SCREWS. 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. 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 THE PATIENT UNDERWENT AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, 9 DAYS POST IMPLANTATION, SURGEON FOUND THREE OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, AS NO REVISION WILL BE PLANNED SO FAR. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921156 ANN BLUNT TIP SCREW 4X48MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3221188 00889024505483

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.