BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODY ASSEMBLY DJD DISTRACTOR II

    MDR report key: 19690370 · Received July 8, 2024

    Report

    Report Number
    0008031020-2024-00260
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 1, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    LXT
    UDI-DI
    07613327073713
    PMA / PMN Number
    K002923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 VERY BAD CONDITION WITH SCRATCHES, DENT AND DEFORMATIONS. BY THE ADJUSTMENT MECHANISM AND IN THE SLEEVE ARE SOME RED FOREIGN SUBSTANCE VISIBLE. FURTHERMORE, THE HINGE IS IN A REALLY BAD CONDITION WITH BLACK 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, VISIBLE AS BASED ON THE CONE FROM RADIALLY RIVETED PROCESS, AND BURR WHICH IS A RESULT OF CONTINUOUSLY MECHANICAL FORCE TO THE RADIALLY RIVETED FROM USE. 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. ALL MEASURE RESULTS ARE WITHIN ACCURACY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. 100% OF THE LOT GOT CHECK FOR HINGE FUNCTION. 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 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

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "THE HINGE PART OF THE DJD2 BODY WAS DISASSEMBLED AND NO LONGER FIXED. IT CONTINUED TO BE USED WITH THE DEFECTIVE PART TAPED IN PLACE."

    Description of Event or Problem · 0

    AS REPORTED: "THE HINGE PART OF THE DJD2 BODY WAS DISASSEMBLED AND NO LONGER FIXED.IT CONTINUED TO BE USED WITH THE DEFECTIVE PART TAPED IN PLACE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894776 BODY ASSEMBLY DJD DISTRACTOR II APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM LXT STRYKER GMBH H32709 07613327073713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention