BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE PIN ADAPTOR HUDSON COUPLING - CONICAL ASSEMBLY

    MDR report key: 12638399 · Received October 15, 2021

    Report

    Report Number
    3005180920-2021-00809
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 17, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040790857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION COMPLETED BY R&D PROJECT MANAGER ON (B)(6) 2021 DURING THE VISUAL INSPECTION, THE PIN ADAPTER WAS CHECKED IN STANDARD CONDITION OF USE. SEVERAL MOTORIZED PINS HAVE BEEN INSERTED AND USED TO FIX METAL CUTTING BLOCKS. THE FIRST CHECK WAS TO COMPARE THE DEVICE WITH OTHER UNITS FROM FINISHED GOODS INVENTORY, WITH NO SIGNIFICANT DIFFERENCE DETECTED REGARDING PIN INSERTION AND PIN STABILITY. IN ORDER TO FULLY EVALUATE THE DEVICE, WE MESURED THE TRIANGULAR CONNECTION, WHICH DETECTED A SLIGHT OFFSET FROM THE STANDARD SPECIFICATIONS, BUT AS THE DEVICE HAS BEEN USED MULTIPLE TIMES WE CANNOT DETERMINE TO WHAT EXTENT THIS HAS BEEN INFLUENCED BY WEAR OVER THE USEFUL LIFE OF THE DEVICE. WE THEN PROCEEDED WITH THE VISUAL AND FUNCTIONAL ANALYSIS OF THE COAXIAL FEATURES DURING ROTATION BETWEEN THE PIN AND THE PIN ADAPTER; A SLIGHT DIFFERENCE WAS DETECTED WHEN COMPARING THE RETURNED DEVICE AND UNITS RETRIEVED FROM FINISHED GOODS INVENTORY, BUT NO CONCLUSION COULD BE MADE REGARDING THIS. ULTIMATELY, WE WERE ABLE TO PROCEED WITH THE FIXATION OF SEVERAL CUTTING BLOCKS TO STANDARD SAWBONES. ALTHOUGH WE COULD NOT REPEAT THE REPORTED ISSUE, IT IS POSSIBLE THAT THE SPECIFIC COMBINATION OF PIN AND PIN ADAPTER MAY HAVE RESULTED IN A OMPROPER ROTATION OF THE PIN WHICH THEN LED TO EXCESSIVE FRICTION DURING PIN INSERTION INTO THE CUTTING GUIDE FIXATION HOLES. THE PIN WAS THEN SIZED DUE TO A COLD WELDING PHEMOMENON.

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED ON 12-NOVEMBER-2021, DEVICE EVALUATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 SEPTEMBER 2021: LOT 1953865: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEPT- 2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED

    Description of Event or Problem · 1

    THE PIN DID NOT ROTATE CORRECTLY WHILE COUPLED WITH THE PIN ADOPTER. PIN METAL DEBRIS WAS OBSERVED WHILE INSERTING IT IN THE TIBIAL CUTTING GUIDE. THE SURGEON COMPLETED THE SURGERY SETTING THE CUT BLOCK BY VISUAL. 30 MINUTES DELAY. TOTAL SURGERY TIME WAS 130 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541538 GMK-SPHERE PIN ADAPTOR HUDSON COUPLING - CONICAL ASSEMBLY KNEE INSTRUMENT PIN ADAPTOR LXH MEDACTA INTERNATIONAL SA 02.07.10.4742 1953865 07630040790857

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other