BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX BIOCRYL 3.3MM FEMORAL ST CROSS PIN KIT

    MDR report key: 3863833 · Received June 10, 2014

    Report

    Report Number
    1221934-2014-00224
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K091041
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE SECOND CROSS PIN KIT CONSISTING OF 2 SLEEVES AND 2 TROCARS WERE RECEIVED AND INSPECTED. VISUALLY, THERE WERE SIGNIFICANT STRIATIONS ON THE EXTERNAL SURFACE OF THE SLEEVES INDICATING THAT IT WAS LOOSELY FIT INSIDE THE GUIDE FRAME. THE TROCARS WERE COLD WELDED TO THE SLEEVES. HISTORICALLY, THERE ARE A COUPLE OF KNOWN FACTORS THAT HAVE BEEN OBSERVED WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS TYPE FAILURE MODE: IF THE PINS ON THE TROCAR ARE NOT FULLY SEATED IN THE SLEEVE PRIOR TO THE ROTATION OF THE TROCAR. IF THERE IS PRESSURE APPLIED TO THE SIDE OF THE SYSTEM (NOT DRILLING IN LINE), AND ANOTHER FACTOR IS IF THE FRAME IS OUT OF STRAIGHTNESS. ALL OF THESE FACTORS WILL CAUSE THE FRAME TO BIND WITH THE SLEEVE/TROCAR RESULTING IN WELDING OF THE TWO PARTS. THIS FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE. PART OF THE ALIGNMENT ISSUE IN THIS CASE WAS CONTRIBUTED BY THE SLEEVE WINDOW ON THE ASSOCIATED FEMORAL ROD. ONE OF THE TROCAR OF THIS KIT HAS THE TIP BROKEN, CONFIRMING THIS COMPLAINT. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY (B)(4) COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE OBSERVED ANOMALIES ON THE SLEEVES AND ASSOCIATED FEMORAL RODS POSSIBLY CONTRIBUTED TO THIS EVENT. APART FROM THIS, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. AT THIS POINT IN TIME, BASED ON THE COMPLAINT HISTORY, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY (B)(4) 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.

    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, 1221934-2014-00220, AND 1221934-2014-00221.

    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, 1221934-2014-00220, AND 1221934-2014-00221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341062 MITEK RIGIDFIX BIOCRYL 3.3MM FEMORAL ST CROSS PIN KIT ACL IMPLANTS MAI DEPUY MITEK NA 3748775

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention