BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNT TIP SCREW, ÿ 4X42MM

    MDR report key: 23437335 · Received October 31, 2025

    Report

    Report Number
    0009613350-2025-00842
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 7, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505452
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H10, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT/INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10. ANN PH NAIL LT 9X160MM; ITEM# 47249616109; ;LOT# 3240560. ANN BLUNT TIP SCREW 4X38MM; ITEM# 47248603840; LOT# 3237433. ANN BLUNT TIP SCREW 4X40MM; ITEM# 47248604040; LOT# 3231475. BLUNT TIP SCREW, ÿ 4X50MM; ITEM# 47248605040; LOT# 3221607. CORTICAL BONE SCREW, ÿ 4X22MM; ITEM# 47248612240; LOT# 3240160. CORTICAL BONE SCREW, ÿ 4X26MM; ITEM# 47248612640; LOT# 3242889. PROXIMAL HUMERUS NAIL CAP, 0MM; ITEM# 47248801000; LOT# 3242939. 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.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH ANN NAIL. THE PROXIMAL SCREWS BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE REDUCTION WAS LOST 4 WEEKS POSTOPERATIVELY. THE CAUSE WAS THAT THE PATIENT HAD DEMENTIA AND WAS UNABLE TO ADHERE TO THE POST-TREATMENT RESTRICTIONS. THE SURGEON 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298771 BLUNT TIP SCREW, ÿ 4X42MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3238860 00889024505452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown