BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN PH NAIL RT 9X160MM

    MDR report key: 23167800 · Received September 29, 2025

    Report

    Report Number
    0009613350-2025-00737
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 8, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    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: 47248603840 ¿ BLUNT TIP SCREW ¿ 3237314. 47248604240 ¿ BLUNT TIP SCREW ¿ 3218970. 47248604240 ¿ BLUNT TIP SCREW ¿ 3234482. 47248606040 ¿ BLUNT TIP SCREW ¿ 3203710. 47248612640 ¿ CORTICAL BONE SCREW ¿ 3235324. 47248612840 ¿ CORTICAL BONE SCREW ¿ 3238263. 47248801000 ¿ PROXIMAL HUMERUS NAIL CAP ¿ 3230200. G2: REPORT SOURCE: JAPAN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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

    FOLLOW UP REPORT. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6. 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. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET, SEE SURGICAL TECHNIQUE. THE SURGICAL TECHNIQUE EXPLAINS THAT THE LOCKING OF THE CORELOCK IS DONE USING THE CORELOCK DRIVER WITH TORQUE LIMITING HANDLE. "TURN SLOWLY CLOCKWISE TO TIGHTEN AND ENGAGE THE CORELOCK MECHANISM UNTIL A CLICK IS FELT FROM THE TORQUE LIMITING HANDLE." REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND THE PART AND LOT COMBINATIONS. COMPLAINTS ARE MONITORED COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. MEDICAL RECORDS WERE NOT PROVIDED. 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 ONE MOTH POST IMPLANTATION OF AN ANN NAIL, THE SURGEON FOUND #3 OF THE PROXIMAL SCREW WAS 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. ALL IMPLANTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144888 ANN PH NAIL RT 9X160MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3234755

    Patients

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