BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN BLUNT TIP SCREW 4X44MM

    MDR report key: 25030396 · Received April 29, 2026

    Report

    Report Number
    0009613350-2026-00230
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: ANN PH NAIL RT 9X160MM; ITEM: 47-2496-160-09; LOT: 3223706. G2: REPORT SOURCE: SPAIN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD UNDERWENT IM NAILING OF THE RIGHT PROXIMAL HUMERUS. SUBSEQUENT X-RAYS REVEALED EVIDENCE OF PROXIMAL SCREW LOOSENING AND PROTRUSION. THE PATIENT IS SCHEDULED FOR SCREW REMOVAL ON AN UNKNOWN DATE DUE TO PAIN FROM THE PROTRUDED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493816 ANN BLUNT TIP SCREW 4X44MM PROSTHESIS, SHOULDER HSB ZIMMER GMBH 3265431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.