BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 6196498 · Received December 21, 2016

    Report

    Report Number
    1221934-2016-10558
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 21, 2016
    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

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, FIBERWIRE IS NOT INTENDED TO BE USED WITH GII ANCHOR AND PER IFU ORTHROCORD SHOULD BE USED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY (B)(4) COMPLAINTS SYSTEM REVEALED ONE SIMILAR COMPLAINT FROM THE SAME FACILITY FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. THE COMPLAINT RATE WAS REVIEWED AGAINST THE RISK ANALYSIS AND IS WELL WITHIN THE EXPECTED RATE. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY (B)(4) 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. (B)(4).

    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

    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 WAS RECEIVED VIA EMAIL FROM THE AFFILIATE ON 12-13- 2016. BOTH SUTURES INITIALLY BROKE ON TWO OF THE GII ANCHORS. THE SURGEON THEN USED ANOTHER GII ANCHOR AND LOADED FIBERWIRE TO COMPLETE THE PROCEDURE WHICH TOOK LESS THAN 30 MINUTES. AS REPORTED IN THE FIRST COMPLAINT (B)(4) A NEW BONE HOLE WAS MADE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843321 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK 3922345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other