BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GII ANCHOR

    MDR report key: 9271891 · Received November 4, 2019

    Report

    Report Number
    1221934-2019-59417
    Event Type
    Injury
    Date Received
    November 4, 2019
    Report Date
    October 31, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TAMAI, K., "CLINICAL RESULTS OF BANKART REPAIR WITH SUTURE ANCHORS" (JAPAN) THIS STUDY EMPHASIZES ON ANALYZING THE CLINICAL RESULTS OF THE BANKART REPAIR USING SUTURE ANCHORS AS COMPARED TO THOSE OF THE CONVENTIONAL TRANSOSSEOUS SUTURE TECHNIQUE. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 83 SHOULDERS IN 83 PATIENTS WITH RECURRENT ANTERIOR INSTABILITY OF THE SHOULDER OF TRAUMATIC ORIGIN WHO UNDERWENT BANKART REPAIR AND FOLLOWED UP FOR MORE THAN ONE YEAR AFTER SURGERY. THERE WERE 68 MALES AND 15 FEMALES. THE AGE AT OPERATION RANGED FROM 15 TO 60 (AVERAGE, 25) YEARS. OF THE 83 PATIENTS, 46 WERE OPERATED WITH THE CONVENTIONAL TRANSOSSEOUS SUTURE TECHNIQUE (GROUP T/, 15 WITH STATAK SOFT-TISSUE ATTACHMENT DEVICE (GROUP S), AND 22 WITH MITEK G II ANCHOR (GROUP M). THE AVERAGE FOLLOW-UP PERIOD WAS 3.7, 2.2 AND 1.5 YEARS, RESPECTIVELY. THE FUNCTIONAL RESULTS WERE ASSESSED WITH ROWE'S SCORING SYSTEM (1978). THE RECURRENCE WAS RECORDED IN ONE PATIENT (2.2%) IN GROUP T, 5 (33%) IN GROUP S AND 3 (14%) IN GROUP M. THE ROWE'S SCORE TOTALED 55-100 (AVERAGE, 89) IN GROUP T, 15-100 (AVERAGE, 72) IN GROUP S AND 25- 100 (AVERAGE, 83) IN GROUP M. EXCELLENT AND GOOD RESULTS WERE OBTAINED IN 40 (87%), 9 (60%) AND 18 (82%) PATIENTS, RESPECTIVELY. DISLODGMENT OF THE SUTURE ANCHOR WAS ENCOUNTERED ONCE IN A PATIENT IN GROUP M. WHEN THE FAIR AND POOR RESULTS WERE ANALYZED, LIMITATION OF POSTOPERATIVE SHOULDER MOTION WAS THE MAJOR HINDRANCE TO SATISFACTORY FUNCTION IN GROUP T, WHEREAS THE HIGH RECURRENCE RATE WAS IN GROUP S AND GROUP M. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: BANKART REPAIR WITH SUTURE ANCHORS THE DEVICES INVOLVED WERE: 46 WERE OPERATED WITH THE CONVENTIONAL TRANSOSSEOUS SUTURE TECHNIQUE (GROUP T/, 15 WITH STATAK SOFT-TISSUE ATTACHMENT DEVICE (GROUP S), AND 22 WITH MITEK G II ANCHOR (GROUP M) COMPLICATIONS MENTIONED IN THE ARTICLE WERE: - DISLODGMENT OF THE SUTURE ANCHOR WAS ENCOUNTERED ONCE IN A PATIENT IN GROUP M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067898 UNKNOWN GII ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention