BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN CORT BONE SCREW 4 X 26MM

    MDR report key: 24440523 · Received February 25, 2026

    Report

    Report Number
    0009613350-2026-00102
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    September 5, 2025
    Report Date
    March 10, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: E1, E3 THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H10, H11. D10: CONCOMITANT MEDICAL PRODUCTS: DESC: ANN AR NAIL 7.5X280MM; ITEM: 47-2497-280-07; LOT: 1718799, DESC: ANN BLUNT TIP SCREW 4X40MM; ITEM: 47-2486-040-40; LOT: 3064863 , DESC: ANN BLUNT TIP SCREW 4X44MM;ITEM: 47-2486-044-40; LOT: 3064865, DESC: ANN BLUNT TIP SCREW 4X50MM; ITEM: 47-2486-050-40; LOT: 3226074, DESC: ANN CORT BONE SCREW 4 X 26MM; ITEM: 47-2486-126-40; LOT: 3227128 , DESC: ANN BLUNT TIP SCREW 4X44MM; ITEM: 47-2486-044-40; LOT: 3064865 . INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CONCOMITANT MEDICAL PRODUCTS: DESC: ANN AR NAIL 7.5X280MM; ITEM: 47-2497-280-07; LOT: 1718799. DESC: ANN BLUNT TIP SCREW 4X40MM; ITEM: 47-2486-040-40; LOT: UNK. DESC: ANN BLUNT TIP SCREW 4X44MM; ITEM: 47-2486-044-40; LOT: UNK. DESC: ANN BLUNT TIP SCREW 4X50MM; ITEM: 47-2486-050-40; LOT: UNK. DESC: ANN CORT BONE SCREW 4 X 26MM; ITEM: 47-2486-126-40; LOT: UNK. DESC: ANN BLUNT TIP SCREW 4X44MM; ITEM: 47-2486-044-40; LOT: UNK. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT LYSIS OF ADHESIONS APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO PAIN AND DECREASED RANGE OF MOTION. THE PATIENT INITIALLY UNDERWENT A RIGHT OPEN REDUCTION INTERNAL FIXATION OF THE TUBEROSITY. SUBSEQUENTLY, LYSIS OF ADHESIONS WAS PERFORMED DUE TO PERSISTENT PAIN AND LIMITED RANGE OF MOTION; ALL COMPONENTS REMAINED IMPLANTED. ALL COMPONENTS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567935 ANN CORT BONE SCREW 4 X 26MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER GMBH 3227128

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| R SEE H11 NARRATIVE| SEE H11 NARRATIVE