BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK INTRAFIX TIBIAL SHEATH, 30 MM

    MDR report key: 3946355 · Received July 21, 2014

    Report

    Report Number
    1221934-2014-00313
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K983560
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SCREW AND SHEATH WERE RECEIVED AND FORWARDED TO NPD ENGINEER FOR EVALUATION. VISUAL INSPECTION REVEALS THE SHEATH IS BROKEN/DAMAGED AT THE PROXIMAL END. THE DAMAGE TO THE SHEATH MIGHT HAVE OCCURRED DURING THE REMOVAL OF THE DEVICE. THE SCREW WAS EXAMINED AND OBSERVED THAT THE NOSE OF THE SCREW IS BROKEN. THE NOSE BREAKAGE INDICATES THAT THE SCREW WAS OVER DRIVEN. BY MEASURING THE DIAMETER OF THE HOLE IN THE NOSE IT WAS OVER DRIVEN APPROX. 5 MM. THIS DAMAGE TO THE SCREW INDICATE THAT THE DEVICE WAS NOT IMPLANTED PROPERLY, WHICH MIGHT HAVE CONTRIBUTED IN THE SYSTEM BACKING OUT OF THE PREPARED HOLE. THE COMPLAINT CAN BE CONFIRMED. FURTHERMORE, NO LOT NUMBERS WERE PROVIDED 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. IF ADDITIONAL INFORMATION IS MADE AVAILABLE TO MITEK COMPLAINTS IN FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND RE-EVALUATED. 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 TRANSIT.

    Description of Event or Problem · 1

    PROCEDURE: REMOVAL OF INTRAFIX TIBIAL SHEATH AND SCREW. IMPLANT HAD PRESENTED AS A LUMP ON PATIENT'S LEFT AM PORTAL SITE FROM A PREVIOUS HAMSTRING ACL. ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE LUMP HAS GIVEN THE PATIENT SOME DISCOMFORT SO REMOVAL OF THE SCREW WAS THE KEY. ON OPENING THE OPERATIVE SITE IT WAS NOTED THAT THE SHEATH AND SCREW TOGETHER HAD BEEN PUSHED OUT OF THE PRIMARY SITE BY 5-10MM, HENCE WHAT THE PATIENT WAS FEELING THROUGH THE SKIN. THE SHEATH AND SCREW WERE TOGETHER. UNSCREWING THE SCREW, THE SHEATH REMAINED AND WAS QUITE SECURE. USING NIBBLERS, THE SHEATH WAS REMOVED AND THE TUNNEL SIZED. THE LENGTH OF THE TUNNEL WAS SHORTENED FROM THE ORIGINAL 30MM AND DID NOT EXTEND INTO THE JOINT, LEAVING WHAT WOULD APPEAR TO BE A 5-7MM PLUG OF BONE IN THE PROXIMAL CANAL. SURGEON USED TUNNEL DILATORS TO SIZE THE CANAL AND INSERTED A 9X23MM MILAGRO ADVANCE SCREW CAT# 231818. THIS ACHIEVED THE DESIRED FIXATION. PATIENT IS (B)(6), MALE. SEE ASSOCIATED MED WATCH # 1221934-2014-00314.

    Description of Event or Problem · 1

    PROCEDURE: REMOVAL OF INTRAFIX TIBIAL SHEATH AND SCREW. IMPLANT HAD PRESENTED AS A LUMP ON PATIENT'S LEFT AM PORTAL SITE FROM A PREVIOUS HAMSTRING ACL. ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE LUMP HAS GIVEN THE PATIENT SOME DISCOMFORT SO REMOVAL OF THE SCREW WAS THE KEY. ON OPENING THE OPERATIVE SITE IT WAS NOTED THAT THE SHEATH AND SCREW TOGETHER HAD BEEN PUSHED OUT OF THE PRIMARY SITE BY 5-10MM, HENCE WHAT THE PATIENT WAS FEELING THROUGH THE SKIN. THE SHEATH AND SCREW WERE TOGETHER. UNSCREWING THE SCREW, THE SHEATH REMAINED AND WAS QUITE SECURE. USING NIBBLERS, THE SHEATH WAS REMOVED AND THE TUNNEL SIZED. THE LENGTH OF THE TUNNEL WAS SHORTENED FROM THE ORIGINAL 30MM AND DID NOT EXTEND INTO THE JOINT, LEAVING WHAT WOULD APPEAR TO BE A 5-7MM PLUG OF BONE IN THE PROXIMAL CANAL. SURGEON USED TUNNEL DILATORS TO SIZE THE CANAL AND INSERTED A 9X23MM MILAGRO ADVANCE SCREW CAT# 231818. THIS ACHIEVED THE DESIRED FIXATION. PATIENT IS 17 YEARS OLD, MALE. SEE ASSOCIATED MED WATCH # 1221934-2014-00314

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426526 MITEK INTRAFIX TIBIAL SHEATH, 30 MM SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention