BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ O/C CP-2 *EA

    MDR report key: 8284915 · Received January 29, 2019

    Report

    Report Number
    1221934-2019-56205
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    October 8, 2016
    Report Date
    October 8, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    PMA / PMN Number
    K051989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. 5 PIECES OF SUTURE WERE RETURNED FOR EVALUATION. VISUAL OBSERVATION REVEALED THAT THE ENDS OF THE SUTURE WERE FRAYED, CONFIRMING THE COMPLAINT. ADDITIONALLY, THE SUTURE WAS HEAVILY STAINED WITH TISSUE DEBRIS AND FLUID. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS POSSIBLE THAT EXCESS TENSION WAS APPLIED TO THE SUTURE CAUSING IT TO BREAK. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PRODUCT CODE 222983 - LOT # 3912140 COMBINATION. REVIEW CONDUCTED PER (B)(4). THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF PROXIMAL HUMERUS PROCEDURE THE SUTURES ON TWO OF THEIR GII ANCHORS WITH ORTHOCORD SNAPPED MID-STRING WHEN GOING TO TIE THE KNOT. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE BY LEAVING THE ANCHORS IN AND TYING A KNOT WITH THE REMAINING THREE INCHES OF SUTURE THAT WAS LEFT WITH NO PATIENT CONSEQUENCES OR DELAYS. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80466 GII QA+ O/C CP-2 *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 3912140 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1