BEUDAMED
    FDA Adverse Event Summary report: N

    GUIDE PIN

    MDR report key: 1082660 · Received July 16, 2008

    Report

    Report Number
    1082660
    Date Received
    July 16, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    MDM
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT INVOLVES A PATIENT WITH A RIGHT KNEE ANTERIOR CRUCIATE LIGAMENT DEFICIENCY, WHO WAS SEEN IN THE SURGEON'S OFFICE WITH MECHANICAL SYMPTOMS AND EPISODES OF GIVING WAY. AN MRI SCAN CONFIRMED A RIGHT KNEE ANTERIOR CRUCIATE LIGAMENT TEAR AND A RIGHT KNEE LATERAL MENISCUS BUCKET-HANDLE TEAR. TREATMENT OPTIONS WERE DISCUSSED WITH THE FAMILY, AND THE PATIENT CONSENTED TO HAVE SURGERY CONSISTING OF A RIGHT KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING ACHILLES ALLOGRAFT, A LATERAL MENISCAL REPAIR, AND AN AUTOLOGOUS TISSUE GRAFT PROCEDURE. THE PATIENT HAD PROPHYLACTIC ANTIBIOTICS PRIOR TO SURGERY AND WAS TAKEN TO THE OR WHERE HE UNDERWENT SUCCESSFUL GENERAL ANESTHESIA AND A KNEE EXAMINATION WHICH CONFIRMED THE DIAGNOSIS. THE SURGEON PERFORMED THE ARTHROSCOPIC PART OF THE PROCEDURE, AND THE SURGEON'S PHYSICIAN ASSISTANT PERFORMED THE ACHILLES ALLOGRAFT FOR IMPLANT. THEY PERFORMED THE MENISCUS REPAIR FOLLOWING DIAGNOSTIC ARTHROSCOPY, USING A PROBE TO REDUCE THE MENISCUS AND TWO ANCHORS TO SUTURE THE MENISCUS TO ITS PERIPHERAL ATTACHMENT. NEXT, THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND THE TIBIAL TUNNEL WERE COMPLETED, AFTER WHICH THE FEMORAL TUNNEL AND GRAFT INJECTION WERE DONE. FOR THE FEMORAL FIXATION, HARDWARE WAS USED TO FIX THE DISTAL PORTION OF THE ACHILLES INTO THE TIBIAL METAPHYSEAL REGION. THERE WAS NO EVIDENCE OF A SCREW PROTRUDING INTO THE KNEE, WHICH WAS FLUSHED AGAIN, AND ALL DEBRIS WAS REMOVED PRIOR TO CLOSING. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM WITH NO APPARENT INTRAOPERATIVE COMPLICATIONS. HOWEVER, THE FOLLOWING DAY, THE PATIENT'S SURGEON REMOVED A PIECE OF GUIDE PIN FROM THE PATIENT'S KNEE WHICH WAS USED IN THE ORIGINAL PROCEDURE. ONE DAY POST-OP, THE SURGEON TOOK AN X-RAY OF THE PATIENT'S KNEE AND CONFIRMED A PIECE OF AN ARTHREX GUIDE DRILL PIN WAS RETAINED WITHIN THE PATIENT'S TENDON GRAFT. THE GUIDE PIN MAY HAVE BEEN BENT WHEN IT WAS GOING INTO THE JOINT, AND WHEN THE SCREW WENT IN, IT MAY HAVE SEVERED THE GUIDE PIN. THE GUIDE PIN WAS PULLED OUT AFTER IT WAS USED TO GUIDE THE SCREW INTO THE TIBIAL TUNNEL. THE PIECE OF THE GUIDE PIN WAS RETAINED WITHIN THE TENDON, AND WAS IMPOSSIBLE TO SEE ARTHROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE PIN HARDWARE, PIN, DRILL GUIDE MDM ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR