BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 23236536 · Received October 7, 2025

    Report

    Report Number
    1644408-2025-01443
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 9, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE H6 AND H11 .THE AGENT REPORTED: LINER BALL IMPACTOR SIZER 44 SPLIT IN CASE. THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THERE WAS A 25 MIN. DELAY IN THE SURGERY. THE SURGERY WAS COMPLETED AS INTENDED. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. WHEN THIS EVENT OCCURRED, THERE WAS ANOTHER SUITABLE DEVICE AVAILABLE?". RMA EXAMINATION: THE REPORTED INSTRUMENT WAS NOT RETURNED TO ENOVIS SURGICAL FOR EVALUATION. NO LOT NUMBER WAS REPORTED. NO FURTHER EVALUATION CAN BE MADE OF THIS EVENT. THIS CUSTOMER COMPLAINT WILL BE CLOSED. IF THE DEVICE IS RETURNED LATER, THE COMPLAINT WILL BE UPDATED. COMPLAINT DATABASE REVIEW SHOWED PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THERE ARE NO INDICATIONS THAT THE ITEM HAS A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH USAGE, NOT A DESIGN OR MANUFACTURING ISSUE. THE REVISION LEVEL OR LOT NUMBER WERE NOT REPORTED; THEREFORE, THE ITEM COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD, OR THE ACTUAL DATE OF MANUFACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. THE ROOT CAUSE IS THE LINER BALL IMPACTOR SPLIT. THE ITEM WAS LOST/DISCARDED THEREFORE THE EVENT CANNOT BE CONFIRMED. THIS EVENT IS POSSIBLY ATTRIBUTABLE THROUGH PROLONGED USE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION OR ISSUE.

    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

    DURING PRIMARY SURGERY, A 44 MM INNER BALL IMPACTOR SIZER SPLIT, CAUSING A 25-MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298472 DJO SURGICAL HXL ACETABULAR LINER IMPACTOR, BALL, 44MM FMP ENCORE MEDICAL L.P. 411872

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other