BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 7069109 · Received November 29, 2017

    Report

    Report Number
    1221934-2017-50010
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K051989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EXPIRATION DATE HAS BEEN UPDATED. THEREFORE, UDI HAS BEEN UPDATED. DATE OF MANUFACTURE HAS BEEN UPDATED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE. THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT, 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).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    THE SALES REP REPORTED VIA PHONE THAT THE SUTURE ON THE CUSTOMER'S GII ANCHOR WITH ORTHOCORD SNAPPED WHEN TYING IT DOWN DURING A BICEP REPAIR. THE ANCHOR WAS LEFT IN THE PATIENT AND AN ARTHREX BUTTON WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SUTURE WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848692 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK L393385

    Patients

    Seq Age Sex Outcome Treatment
    1 Other