BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANN PH NAIL RT 7X160MM

    MDR report key: 24720093 · Received March 30, 2026

    Report

    Report Number
    0009613350-2026-00200
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505773
    PMA / PMN Number
    K231114
    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. BLUNT TIP SCREW, 4X40MM ITEM#: 47248604040 LOT#: 3242834. BLUNT TIP SCREW, 4X40MM ITEM#: 47248604040 LOT#: 3240205. BLUNT TIP SCREW, 4X40MM ITEM#: 47248604040 LOT#: 3225016. CORTICAL BONE SCREW, 4X26MM ITEM#: 47248612640 LOT#: 3232085. CORTICAL BONE SCREW, 4X26MM ITEM#: 47248612640 LOT#: 3240161. PROXIMAL HUMERUS NAIL CAP, 0MM ITEM#: 47248801000 LOT#: 3238233. G2: FOREIGN - EVENT OCCURRED IN SPAIN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A RETROSPECTIVE CLINICAL STUDY THAT A PATIENT HAD AN INITIAL INTRAMEDULLARY NAILING OF THE RIGHT HUMERUS. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE APPROXIMATELY 7 MONTHS LATER DUE TO NAIL PROMINENCE. X-RAYS REVEALED RADIOLOGICAL PROTRUSION WITHOUT CLINICAL SYMPTOMS. THE PATIENT REMAINED SATISFIED THROUGHOUT THE STUDY, AND THE BONE HAD HEALED PRIOR TO EXPLANTATION. 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
    781222 ANN PH NAIL RT 7X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3177555 00889024505773

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H11 NARRATIVE