BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD

    MDR report key: 5102197 · Received September 24, 2015

    Report

    Report Number
    1221934-2015-00987
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    August 28, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K120078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY BEING INVESTIGATED. WHEN THE EVALUATION RESULTS ARE AVAILABLE, A FOLLOW UP MEDWATCH REPORT WILL BE FILED. UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. IT WAS NOTED THAT ONLY THE ANCHOR HAD BEEN RETURNED. THE SUTURE AND INSERTER WERE NOT RETURNED. INSPECTION OF ANCHOR DISTAL TIP REVEALS A SMALL CRACK IN THE ANCHOR. THE PROXIMAL END OF THE ANCHOR HAS BEEN FLATTENED. THIS WAS PROBABLY CAUSED BY THE REMOVAL OF THE ANCHOR OR COULD HAVE HAPPENED IN TRANSIT. THE THREADS ON THE ANCHOR APPEAR STRESSED CONSISTENT WITH IT BEING INSERTED INTO THE BONE. IT CAN BE CONFIRMED THAT THIS ANCHOR PULLED OUT. TYPICALLY, ANCHOR PULL OUTS ARE ASSOCIATED WITH INCOMPLETE INSERTION INTO THE BONE HOLE, USING INSTRUMENTS NOT INDICATED TO BE USED WITH THE ANCHOR, POOR BONE QUALITY AND APPLYING EXCESS FORCE ON SUTURE DURING TENSIONING. ALTHOUGH WE CANNOT DISCERN A ROOT CAUSE, ANY OF THE AFOREMENTIONED FACTORS OR A COMBINATION OF FACTORS COULD POSSIBLY LEAD TO THIS FAILURE. THIS COMPLAINT CAN BE CONFIRMED. A BATCH REVIEW WAS NOT CONDUCTED AS THE BATCH NUMBER IS UNKNOWN. HOWEVER, DEPUY SYNTHES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ARCR SURGERY THE SURGEON FOUND BY IMAGES THAT THE DEVICE INSERTED OUTSIDE THE GREATER TUBERCLE OF HUMERUS HAD COME OFF ALTHOUGH THE PATIENT WAS GOING TO LEAVE THE HOSPITAL SOON. THE DEVICE IN QUESTION IS NOW PUT UNDER THE ACROMION. THE SURGEON REPORTED THAT HE HAD INSERTED THE DEVICE PROPERLY. THERE IS NO PAIN WITH THE PATIENT AND HE IS UNDER OBSERVATION. REVISION HAS NOT BEEN PLANNED YET. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE VIA E-MAIL ON (B)(6) 2015. THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN. THE REVISION SURGERY OCCURRED ON (B)(6). THE AFFILIATE INDICATED THAT THEY WERE NOTIFIED OF THE EVENT SOMETIME IN (B)(6). THE AFFILIATE PROVIDED PRODUCT CODE 222298 FOR THE FAILED DEVICE BUT THE LOT NUMBER OF THE DEVICE IS UNKNOWN. THE SURGEON USED AN AWL TO PREPARE THE BONE HOLE. THE DEVICE HAD PULLED OUT OF THE BONE HOLE AND IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE AFFILIATE WAS ABLE TO PROVIDE THE ALERT DATE AS (B)(6) 2015. AFFILIATE HAS ALSO INDICATED THAT THE REVISION SURGERY TOOK PLACE ON (B)(6) AND THE DEVICE IN QUESTION WILL BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ARCR SURGERY THE SURGEON FOUND BY IMAGES THAT THE DEVICE INSERTED OUTSIDE THE GREATER TUBERCLE OF HUMERUS HAD COME OFF ALTHOUGH THE PATIENT WAS GOING TO LEAVE THE HOSPITAL SOON. THE DEVICE IN QUESTION IS NOW PUT UNDER THE ACROMION. THE SURGEON REPORTED THAT HE HAD INSERTED THE DEVICE PROPERLY. THERE IS NO PAIN WITH THE PATIENT AND HE IS UNDER OBSERVATION. REVISION HAS NOT BEEN PLANNED YET. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE VIA E-MAIL ON 9/8/2015. THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN. THE REVISION SURGERY OCCURRED ON (B)(6). THE AFFILIATE INDICATED THAT THEY WERE NOTIFIED OF THE EVENT SOMETIME IN (B)(4). THE AFFILIATE PROVIDED PRODUCT CODE 222298 FOR THE FAILED DEVICE BUT THE LOT NUMBER OF THE DEVICE IS UNKNOWN. THE SURGEON USED AN AWL TO PREPARE THE BONE HOLE. THE DEVICE HAD PULLED OUT OF THE BONE HOLE AND IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE AFFILIATE WAS ABLE TO PROVIDE THE ALERT DATE AS AUGUST 28, 2015. AFFILIATE HAS ALSO INDICATED THAT THE REVISION SURGERY TOOK PLACE ON (B)(6) AND THE DEVICE IN QUESTION WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632385 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD ANCHOR IMPLANTS MAI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R