BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 6198296 · Received December 22, 2016

    Report

    Report Number
    1221934-2016-10560
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 22, 2016
    Report Date
    March 2, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K051989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO DOCUMENT THE COMPLAINT DEVICE RETURN TO MITEK, ALONG WITH PRODUCT LOT INFORMATION AND CORRECTIONS. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    THE TWO COMPLAINT DEVICES WERE NOT RETURNED. ONE NEW REPRESENTATIVE SAMPLE FROM THE SAME LOT AS THE COMPLAINT DEVICES WAS RECEIVED FROM THE CUSTOMER. A VISUAL OBSERVATION OF THE DEVICE SHOWED NO ANOMALIES TO THE DEVICE OR THE SUTURE ATTACHED TO THE ANCHOR AND ITS NEEDLES. THREE DIFFERENT SAMPLES WERE TAKEN FROM THE ANCHOR¿S SUTURE AND WERE PULL TESTED. ALL THREE SAMPLES PASSED THE PULL TEST; ALL EXCEEDED THE MINIMUM STRENGTH SPECIFICATION. A DEVICE HISTORY RECORD REVIEW (ON BOTH THE FINISHED PRODUCT CODE LOT AND THE SUTURE PRODUCT CODE LOT) HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. THERE WERE NO ANOMALIES OR DISCREPANCIES IN THE MANUFACTURE OF THE ANCHOR LOT, AND THERE WAS ONE UNRELATED NONCONFORMANCE DURING THE MANUFACTURE OF THE SUTURE LOT. THE SUTURE PASSED ALL TESTS DURING THE MANUFACTURING PROCESS. THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT, FROM THE SAME FACILITY, FOR THIS LOT OF DEVICES THAT WERE RELEASED FOR DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE, ALTHOUGH ONE POSSIBLE ROOT CAUSE COULD BE THAT AN INSTRUMENT BEING USED IN THE PROCEDURE HAD A SHARP EDGE ON IT; RESULTING IN THE ORTHOCORD SUTURE BEING FRAYED OR CUT. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. 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. UDI: (B)(4). COMPLAINT DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER USED 4 IMPLANTS FROM SAME LOT NUMBER AS THE REMAINING ON SHELF, NOW SENT IN AS A COMPLAINT, ON ALL 4 THE SUTURE BROKE VERY EASILY WITHOUT ANY UNUSUAL EXTRA FORCE APPLIED. NEW MITEK GII ANCHORS WERE LOADED WITH ARTHREX FIBERWIRE SUTURE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 11-29-16: THE PROCEDURE WAS A DISTAL BICEPS TENDON RUPTURE, SINGLE INCISION. THE QUANTITY OF ANCHORS THAT FAILED WAS 4 TWO ON EACH PROCEDURE. THE SURGEON WAS TYING THE SUTURES WHEN THEY BROKE. IT WAS THE SAME ON ALL FOUR ANCHORS. THE ANCHORS WERE LEFT IMPLANTED IN THE HOLES. THE SURGEON COMPLETED THE PROCEDURE BY DRILLING NEW HOLES AND LOADED THE NEW ANCHORS WITH FIBERWIRE. WERE THERE ANY PATIENT CONSEQUENCES? HAPPENED TWICE. FIRST TIME AN ADDITIONAL ANCHOR WITH ORTHOCORD WAS IMPLANTED, BUT THAT ANCHOR BROKE AND HE WAS RE-OPERATED ACCORDING TO ABOVE. THE SECOND TIME THE DOCTOR WAS THINKING IT MIGHT BE THE THREADS, SO HE MADE IT ALL OVER. FOR THE FIRST PATIENT A RE-OPERATION AND LONGER IMMOBILIZATION. FOR THE SECOND PATIENT, TO SOME EXTENT LONGER SURGERY TIME AND INCREASED RISK FOR INFECTION. THE COMPLAINT FORMS SHOWS (1) DEVICE IS COMING BACK, WHAT IS COMING BACK? 1 ANCHOR FROM THE SAME LOT NUMBER SERIES THAT WAS KEPT ON THE SHELF. SEE ASSOCIATED MEDWATCH NUMBER 1221934-2016-10561.

    Description of Event or Problem · 1

    NEW MITEK GII ANCHORS WERE LOADED WITH ARTHREX FIBERWIRE SUTURE. THE CUSTOMER USED 4 IMPLANTS FROM SAME LOT NUMBER AS THE REMAINING ON SHELF, NOW SENT IN AS A COMPLAINT, ON ALL 4 THE SUTURE BROKE VERY EASILY WITHOUT ANY UNUSUAL EXTRA FORCE APPLIED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 11-29-2016. THE PROCEDURE WAS A DISTAL BICEPS TENDON RUPTURE, SINGLE INCISION. THE QUANTITY OF ANCHORS THAT FAILED WAS 4 TWO ON EACH PROCEDURE. THE SURGEON WAS TYING THE SUTURES WHEN THEY BROKE. IT WAS THE SAME ON ALL FOUR ANCHORS. THE ANCHORS WERE LEFT IMPLANTED IN THE HOLES . THE SURGEON COMPLETED THE PROCEDURE BY DRILLING NEW HOLES AND LOADED THE NEW ANCHORS WITH FIBERWIRE. WERE THERE ANY PATIENT CONSEQUENCES? HAPPENED TWICE. FIRST TIME, AN ADDITIONAL ANCHOR WITH ORTHOCORD WAS IMPLANTED, BUT THAT ANCHOR BROKE AND HE WAS RE-OPERATED ACCORDING TO ABOVE. THE SECOND TIME THE DOCTOR WAS THINKING IT MIGHT BE THE THREADS, SO HE MADE IT ALL OVER. FOR THE FIRST PATIENT, A RE-OPERATION AND LONGER IMMOBILIZATION. FOR THE SECOND PATIENT, TO SOME EXTENT LONGER SURGERY TIME AND INCREASED RISK FOR INFECTION. THE COMPLAINT FORMS SHOWS (1) DEVICE IS COMING BACK, WHAT IS COMING BACK? ONE ANCHOR FROM THE SAME LOT NUMBER SERIES THAT WAS KEPT ON THE SHELF. WILL CREATE A SECOND COMPLAINT SINCE THIS FAILURE HAPPENED TWICE. ON 12-5-2016 SECOND COMPLAINT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850983 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK 3922345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other