BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX CORING REAMER REMOVAL TOOL

    MDR report key: 2483175 · Received March 1, 2012

    Report

    Report Number
    3006108336-2012-00001
    Event Type
    Other
    Date Received
    March 1, 2012
    Date of Event
    October 4, 2011
    Report Date
    February 29, 2012
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORING REAMER WAS NOT RETURNED FOR EVAL. FROM THE DATE OF RECEIVING THE REPORT, THE SURGEON WAS CONTACTED SEVERAL TIMES FOR ADD'L INFO BUT THE CONTACTS WERE UNSUCCESSFUL. IT IS POSSIBLE THAT THE REAMER WAS DAMAGED DUE TO THE OFF-AXIS USE IN THE TUNNEL. THIS SITUATION IS POSSIBLE WHEN THE GUIDE DRILL IS INSERTED INTO THE IMPLANT AND BECAUSE OF THE MISMATCH BETWEEN THE TIBIAL AND FEMORAL TUNNELS, THE REAMER MAY BE INSERTED AT A DIFFERENT ANGLE. THE DRILL STOP ON THE DRILL GUIDE IS DESIGNED TO KEEP THE REAMER CONCENTRIC TO THE DRILL RESULTING IN CLEAN IMPLANT REMOVAL. IN THIS CASE, THE DRILL STOP ON THE DRILL GUIDE MAY NOT HAVE BEEN VISIBLE BY THE SURGEON. AS THE REAMER WAS INSERTED INTO THE TUNNEL AND USED WITH EXTREME FORCE, THE REAMER'S TEETH AND BODY CONTACTED THE DRILL STOP WHEN THE INSTRUMENT WAS ROTATED BY THE DRILL. THIS METAL TO METAL CONTACT MUSHROOMED THE INTERNAL TEETH AND MAKING IT DIFFICULT TO REMOVE FROM THE KNEE. DURING PROPER ON-AXIS DEPLOYMENT OF THE REAMER, THE TEETH END OF THE REAMER WILL BE SLID OVER THE DRILL STOP PRIOR TO ROTATION. THIS WILL CENTER THE REAMER ON-AXIS TO THE DRILL GUIDE AND PROTECT THE TEETH AND REAMER BODY FROM CONTACTING THE DRILL STOP LEAVING THE TEETH SHARP FOR IMPLANT REMOVAL AND BODY UNDAMAGED.

    Description of Event or Problem · 1

    AN APERFIX CORING REAMER IMPLANT REMOVAL TOOL WAS USED IN A REVISION CASE TO REMOVE AN APERFIX FEMORAL IMPLANT. THE SURGEON REPORTED THAT THE APERFIX CORING REAMER TEETH "MUSHROOMED" WHEN REMOVING THE IMPLANT CAUSING DIFFICULTY FOR THE SURGEON TO REMOVE THE CORING REAMER FROM THE KNEE. THE SURGEON HAD TO REMOVE THE CORING REAMER BACK THROUGH THE TIBIA CREATING A LARGER THAN REQUIRED TUNNEL SIZE. THE CORING REAMER WAS NOT RETURNED TO CAYENNE MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APERFIX CORING REAMER REMOVAL TOOL REAMER HTO CAYENNE MEDICAL, INC. CM-7110-ST 088K19311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention