BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, ÿ 4X38MM

    MDR report key: 19994475 · Received August 15, 2024

    Report

    Report Number
    0009613350-2024-00378
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505438
    PMA / PMN Number
    K200814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: PRODUCT ID WAS PROVIDED FOR THREE SCREWS HOWEVER, IT IS UNKNOWN WHICH OF THE THREE SCREWS HAS MIGRATED. THEREFORE, THE MIGRATED SCREW COULD BE ANY OF THE FOLLOWING: 47248603440 - BLUNT TIP SCREW, ÿ 4X34MM - 3181269; UDI: (B)(4); MANUFACTURING DATE: NOV 2, 2023; EXPIRATION DATE: NOV 2, 2028. 47248603840 - BLUNT TIP SCREW, ÿ 4X38MM - 3190919; UDI: (B)(4); MANUFACTURING DATE: JAN 24, 2024; EXPIRATION DATE: JAN 24, 2029. 47248604240 - ANN BLUNT TIP SCREW 4X42MM - 3185190; UDI: (B)(4); MANUFACTURING DATE: DEC 5, 2023; EXPIRATION DATE: DEC 5, 2028. D10: 47249622108 - PROXIMAL HUMERUS, LEFT, LONG, ÿ 8.5X220MM - 3177532; 47248603440 - BLUNT TIP SCREW, ÿ 4X34MM - 3181269; 47248604240 - ANN BLUNT TIP SCREW 4X42MM - 3185190; 47248612440 - ANN CORT BONE SCREW 4 X 24MM - 3193267; 47248801000 - AFFIXUS PH NL CAP 0MM - 3189255. 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 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT THE #1 AND #3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREWS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200741 BLUNT TIP SCREW, ÿ 4X38MM TRAUMA, INSTRUMENTS. HSB ZIMMER GMBH N/A 3190919 00889024505438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.