BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER PASSIVE TENDON IMPLANT 4MM X 25CM

    MDR report key: 23821728 · Received December 16, 2025

    Report

    Report Number
    3010667733-2025-01525
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 18, 2025
    Report Date
    March 24, 2026
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HXR
    UDI-DI
    00840420132345
    PMA / PMN Number
    K853436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE BECAUSE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT IDENTIFY ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT IDENTIFY ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL-RELATED, MANUFACTURING-RELATED, OR DESIGN-RELATED ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. MORE DETAILED INFORMATION REGARDING THE COMPLAINT EVENT, INCLUDING PREOPERATIVE AND POSTOPERATIVE RADIOGRAPHS AS WELL AS THE AFFECTED DEVICE, IS REQUIRED IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STANDARD HUNTER TENDON ROD FAILED IN PATIENT. THE PHYSICIAN EXPLAINED THAT THE SUTURE TIED INTO IMPLANT BROKE/IMPLANTS CORE SEEMED HOLLOWED OUT. REPLACED WITH SAME ROD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STANDARD HUNTER TENDON ROD FAILED IN PATIENT. THE PHYSICIAN EXPLAINED THAT THE SUTURE TIED INTO IMPLANT BROKE/IMPLANTS CORE SEEMED HOLLOWED OUT. REPLACED WITH SAME ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50529 HUNTER PASSIVE TENDON IMPLANT 4MM X 25CM SPATULA, ORTHOPEDIC HXR WRIGHT MEDICAL TECHNOLOGY INC 1809506 00840420132345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention