BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII EASY ARTHRO #2 ETH *EA

    MDR report key: 8270294 · Received January 23, 2019

    Report

    Report Number
    1221934-2019-56090
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 22, 2016
    Report Date
    December 22, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705002061
    PMA / PMN Number
    K915889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE LOT NUMBER IS CURRENTLY UNAVAILABLE; THEREFORE, THE EXP DATE IS UNAVAILABLE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICES ARE NOT BEING RETURNED, THEREFORE ARE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR ANY OF THESE POTENTIAL LOTS THAT WERE RELEASED TO DISTRIBUTION. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (212450) AND ALL THREE LOTS: LOT # 3901039, LOT # 3915725, LOT # 3927556. NO NON-CONFORMANCES WERE IDENTIFIED FOR ANY OF THE PART-LOT COMBINATION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. HOWEVER, DEPUY 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE ANCHORS WHERE THE SUTURE FRETTED AND BROKE UNDER MINIMAL TENSION IN A G2 ANCHOR. IT WAS REPORTED THAT TWO HAD BEEN SWITCHED OUT FOR ORTHOCORD. IT WAS REPORTED THAT THE ANCHORS WERE BEING USED TO 'SHUTTLE' THE DISTAL BICEPS TENDON DOWN HAVING BEEN WHIP STITCHED BY ONE LIMB OF SUTURE. ACCORDING TO THE REPORTER, THE SUTURES FRAYED ON A 'SHARP EDGE' AT THE ISLET. IT WAS REPORTED THAT THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT HARM AS FURTHER ANCHORS WERE PLACED INTO THE SAME DRILL HOLES TO SECURE THE TENDON. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63421 GII EASY ARTHRO #2 ETH *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US UNK 10886705002061

    Patients

    Seq Age Sex Outcome Treatment
    1