BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX FEMORAL IMPLANT WITH INSERTER

    MDR report key: 1790930 · Received August 3, 2010

    Report

    Report Number
    3006108336-2010-00001
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K073054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FINISHED GOODS LOT 088802110B WAS RELEASED ON 02/09/10 WITH (B)(4). SO FAR, THERE HAS BEEN NO OTHER SCREW FRACTURE COMPLAINT FROM THIS LOT OR ANY OTHER APERFIX FEMORAL STAINLESS STEEL FINISHED GOOD LOT. THE STAINLESS STEEL SCREW (P/N 10730) LOT NUMBER USED IN THIS LOT WAS 1120903 WHICH HAD BEEN RELEASED ON 11/16/2009. ALL THE MATERIAL CERTIFICATES, VISUAL AND DIMENSIONAL INSPECTIONS WERE ACCEPTABLE. THE MATERIAL CERTIFICATE SHOWS THE MINIMUM TENSILE STRENGTH OF 177.724 KSI WHICH MEETS THE PART'S SPECIFICATION. THERE IS ONLY ONE POSSIBLE SITUATION THAT WOULD LEAD TO THIS FAILURE: IF THE IMPLANT WAS PRESSED AND BENT AGAINST THE TUNNEL WALL DURING INSERTION, THE SCREW HEAD WOULD NO LONGER BE AXIAL TO THE SHAFT AND DEFLECT WHEN THE DEPLOYMENT KNOB WAS BEING TURNED. THE CONTINUOUS DEFLECTION OF THE SCREW DURING DEPLOYMENT COULD CAUSE THE SCREW HEAD FRACTURE. AFTER EVAL OF THE SCREW WE WERE ABLE TO VERIFY SCRATCH MARKS ON THE HEAD OF THE SCREW THAT HAD BEEN CREATED WHILE THE SCREW WAS BENT AND SCRAPING AGAINST THE ADJACENT METAL COMPONENT (THREADED SHAFT). CONCLUSION: FAULT POSITIONING OF THE IMPLANT IN THE FEMORAL TUNNEL WHILE DEPLOYING IT.

    Description of Event or Problem · 1

    AN APERFIX FEMORAL SCREW HEAD BROKE AFTER IMPLANTATION AND POST-OP. PT WENT FOR FOLLOW UP APPOINTMENT WITH THE SURGEON BUT WAS NOT REPORTING ANYTHING SPECIFIC OTHER THAN SOME PAIN AND INFLAMMATION SINCE SURGERY FROM THE PRIOR WEEK. THE SURGEON TOOK AN X-RAY AND DISCOVERED THE HEAD OF THE FEMORAL IMPLANT SCREW JUST SEVERAL MILLIMETERS INFERIOR TO THE SCREW. A SECOND X-RAY WAS PERFORMED WITHIN A COUPLE OF DAYS THAT SHOWED THE SCREW HEAD HAD MIGRATED TOWARDS THE POSTERIOR/LATERAL REGION IN THE KNEE. ON (B)(6) 2010, THE SURGEON PERFORMED THE KNEE ARTHROSCOPY AND REMOVED THE SCREW HEAD. ALTHOUGH THE SCREW HEAD WAS DETACHED FROM THE SCREW BODY, THE ACL WAS STILL INTACT AND THE IMPLANT FIXATION WAS SOLID AND SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APERFIX FEMORAL IMPLANT WITH INSERTER BONE SCREW HWC CAYENNE MEDICAL, INC. CM2910 088802110B

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention