BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX FEMORAL ROD 8MM ST

    MDR report key: 3863836 · Received June 10, 2014

    Report

    Report Number
    1221934-2014-00220
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THAT THE WINDOW ON THE FEMORAL ROD WHERE THE SLEEVE PASSES THROUGH HAS MELTED CAUSING UNEVEN EDGES, WHICH IS CONTRIBUTING TO THE MISALIGNMENT ISSUES. THE FEMORAL ROD ITSELF IS NOT BENT. THE FEMORAL RODS ARE REUSABLE AND THIS FAILURE IS TYPICALLY OBSERVED DUE TO HEAVY USAGE OVER A PERIOD OF TIME. VISUALLY, THE ROD LOOKS WORN AND THE LASER MARKINGS ARE SLIGHTLY FADED INDICATING THEY ARE OLD AND HEAVILY USED. THE FAILURE CAN BE ATTRIBUTED TO NORMAL FIELD WEAR. FURTHERMORE, NO LOT NUMBER WAS SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT. IN PROCESS.

    Description of Event or Problem · 1

    SURGEON WAS DRILLING TROCAR AND SLEEVES, BUT COULD NOT. REPOSITIONED WITH SAME OUTCOME. TIP OF TROCAR BROKE INSIDE PATIENT. CALLED RADIOLOGY TO RETRIEVE TIP. HAD SUCCESS RETRIEVING TIP. HAD TO OPEN 2ND RIGIDFIX KIT. AGAIN HAD TROUBLE DRILLING TROCAR AND SLEEVE. NOTICED THAT TROCAR TIP WAS DAMAGED. OPENED 3RD RIGIDFIX KIT AND USED 2ND RIGIDFIX TRAY TO GET NEW SOFT TISSUE GUIDE AND AIMER. FINALLY SUCCESSFUL IN DRILLING SLEEVE AND FINISHED CASE WITH NO FURTHER PROBLEMS. THE PROCEDURE WAS DELAYED 45 MINUTES. SEE ASSOCIATED MEDWATCH #'S 1221934-2014-00219,1221934-2014-00221, AND 1221934-2014-00224.

    Description of Event or Problem · 1

    SURGEON WAS DRILLING TROCAR AND SLEEVES, BUT COULD NOT. REPOSITIONED WITH SAME OUTCOME. TIP OF TROCAR BROKE INSIDE PATIENT. CALLED RADIOLOGY TO RETRIEVE TIP. HAD SUCCESS RETRIEVING TIP. HAD TO OPEN 2ND RIGIDFIX KIT. AGAIN HAD TROUBLE DRILLING TROCAR AND SLEEVE. NOTICED THAT TROCAR TIP WAS DAMAGED. OPENED 3RD RIGIDFIX KIT AND USED 2ND RIGIDFIX TRAY TO GET NEW SOFT TISSUE GUIDE AND AIMER. FINALLY SUCCESSFUL IN DRILLING SLEEVE AND FINISHED CASE WITH NO FURTHER PROBLEMS. THE PROCEDURE WAS DELAYED 45 MINUTES. SEE ASSOCIATED MEDWATCH #'S 1221934-2014-00219,1221934-2014-00221, AND 1221934-2014-00224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341063 MITEK RIGIDFIX FEMORAL ROD 8MM ST ACL INSTRUMENTS FZX DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention