BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJD BODY ASSEMBLY DISTRACTOR II

    MDR report key: 24122964 · Received January 20, 2026

    Report

    Report Number
    0008031020-2026-00049
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 25, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    LXT
    PMA / PMN Number
    K002923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: PLEASE REFER TO SECTIONS D9 THE DEVICE WAS RETURNED AND H6 (METHOD, RESULTS AND CONCLUSION CODES). THE COMPLAINT COULD BE CONFIRMED, SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: VISUAL EXAMINATION OF THE RECEIVED PRODUCT SHOWS THAT THE INSTRUMENT IS IN A WELL-USED CONDITION WITH SCRATCHES, DENT AND DEFORMATIONS. FURTHERMORE, THE HINGE IS IN A REALLY BAD CONDITION WITH FOREIGN SUBSTANCE (STICKY) AND DEFORMATION, FROM USE. IN ADDITION, MICROSCOPIC INVESTIGATION HAS SHOWN THAT THERE ARE CLEAR INDICATIONS THAT THE RADIALLY RIVETED (FLANGED) GOT DAMAGED AFTER MANUFACTURING AND BASED ON THAT WAS ABLE TO FALL OFF, THE SLEEVE SHOWS STRONG SIGNS OF WEAR FROM CONSTANT MOVEMENT. FUNCTIONAL EXAMINATION OF THE RECEIVED PRODUCT SHOWS THAT THE INSTRUMENT WAS RECEIVED WITH COMPLETELY BLOCKED ADJUSTMENTS MECHANISM IN FAR SHORT CONDITION, WITH FORCE WE WERE ABLE TO UNBLOCK THE INSTRUMENT. FURTHERMORE, WE ARE ABLE TO CONFIRM THAT THE HINGE CAN BE DISASSEMBLED, AS THE SLEEVE CAN BE REMOVED AND BASED ON THAT THE HINGE WILL FALL APART. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USE RELATED ISSUE. THE FAILURE WAS CAUSED MOST LIKELY BY THE COLLAPSE OF THE RADIALLY RIVETED AS RESULT OF CONTINUOUSLY MECHANICAL FORCE. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "IT WAS SCHEDULED FOR USE IN SURGERY, BUT IT APPEARS THE HINGE PART CAME LOOSE DURING ASSEMBLY OF THE EXTERNAL FIXATOR."

    Description of Event or Problem · 0

    AS REPORTED: "IT WAS SCHEDULED FOR USE IN SURGERY, BUT IT APPEARS THE HINGE PART CAME LOOSE DURING ASSEMBLY OF THE EXTERNAL FIXATOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24155 DJD BODY ASSEMBLY DISTRACTOR II APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM LXT STRYKER GMBH AU3335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown