BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIMAGNUM KNOTLESS FIXATION DEVICE

    MDR report key: 962220 · Received November 12, 2007

    Report

    Report Number
    2032380-2007-00012
    Event Type
    Other
    Date Received
    November 12, 2007
    Date of Event
    October 24, 2007
    Report Date
    December 6, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    MAI
    PMA / PMN Number
    K042594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTS WERE NOT RETURNED TO THE MFR FOR EVAL. THE SALES REP WAS PRESENT FOR THE SURGERY CONDUCTED IN 2007 AND OBSERVED THE EXPLANTED ANCHORS. BOTH APPEARED TO HAVE PROPERLY IMPLANTED WITH SUTURE LOCK DEPLOYED AS EVIDENCED BY VISUAL EXAMINATION. IT WAS NOTED THAT THE BONE LOCK MECHANISM (THE "WINGS") HAD BROKEN OFF OF THE ANCHORS. ARTHROCARE REVIEWED PROD COMPLAINT DATA FOR THIS FAILURE MODE. INCIDENT RATE IS LESS THAN 1%. NO CONCLUSION CAN BE CONFIRMED RELATED TO THIS INCIDENT. THIS MDR IS FOR ONE OF TWO DEVICES THAT EXHIBITED FAILURE MODES DURING THE SURGERY REPORTED IN 2007. THE REPORT FOR THE SECOND DEVICE USED IS SUBMITTED UNDER CROSS REFERENCE MDR 2032380-2007-00013. REF: ARTHROCARE RMA, MDR FAXED TO FDA 12/06/2007.

    Description of Event or Problem · 1

    ON 10/29/2007, ARTHROCARE REC'D A REPORT INVOLVING A MINIMAGNUM KNOTLESS FIXATION DEVICE. DURING THE INITIAL LABRAL REPAIR SURGERY, THREE BONE ANCHORS WERE PLACED ARTHROSCOPICALLY TO A RIGHT SHOULDER INJURY WITH DISLOCATION. PT EXPERIENCED PAIN POSTOPERATIVELY, BUT IT WAS CONSIDERED TO BE NORMAL SURGICAL PAIN. THE PAIN PERSISTED. IN 2007, A SECOND SURGERY WAS PERFORMED. OF THE THREE IMPLANTS, THE MEDIAL ANCHOR WAS INTACT AND IN PLACE. THE PROXIMAL AND DISTAL IMPLANTS WERE LOOSE FROM THEIR BONE HOLE. THE TWO LOOSE ANCHORS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMAGNUM KNOTLESS FIXATION DEVICE FASTENER, FIXATION, BIODEGRADEABLE MAI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other