BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 23270836 · Received October 10, 2025

    Report

    Report Number
    1644408-2025-01470
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 12, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    PMA / PMN Number
    K100741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED AS, REVISION SURGERY: "PATIENT HAD DISCOMFORT SO DOCTOR WANTED TO SWITCH OUT SIZES" THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM(S) LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. NOTE: ITEM CHANGED TO UNKNOWN. THE REPORTED AFFECTED ITEM WAS ENTERED IN ERROR; THE ITEM WAS FOUND TO BE A DUPLICATE OF THE ITEM ON THE CURRENT REVISION DTICKET. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE REVISED ITEM(S) WAS NOT RETURNED FOR EXAMINATION AND THE ITEM AND OR LOT NUMBER(S) WAS NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE PART AND LOT NUMBER(S) ARE NECESSARY. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO OTHER INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.

    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 DURING SURGERY, A PIECE OF A LOCKING SCREW BROKE OFF IN THE BASEPLATE AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424846 DJO SURGICAL 44MM RSP GLEN HD +8MM,   KWS ENCORE MEDICAL L.P. 877C1236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male