BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 4201635 · Received October 27, 2014

    Report

    Report Number
    1221934-2014-00467
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K051989
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR A PHYSICAL EVALUATION. THE CASE WAS DISCUSSED WITH THE MEDICAL SAFETY TEAM AND THE NPD QUALITY ENGINEER. THE DESIGN AND MATERIAL FEATURES WERE REVIEWED AND DID NOT APPEAR TO HAVE ANY EFFECT ON THE REPORTED PATIENT ISSUE. A BATCH REVIEW WAS CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. A REVIEW OF LAST 12 MONTHS COMPLAINT DATA DID NOT REVEAL ANY SIMILAR COMPLAINTS FOR THIS PRODUCT. AS INDICATED FROM THE PRODUCT AND LOT REVIEWS, THE EVENT DOES NOT APPEAR TO BE PRODUCT RELATED. BASED ON THE COMPLAINT HISTORY, AT THIS POINT IN TIME, NO FURTHER ACTIONS ARE WARRANTED. HOWEVER, 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT POST OP OF AN OPEN RIGHT ELBOW REPAIR THAT THE PATIENT'S INCISION STARTED DRAINING. THE SURGEON DID A FOLLOW-UP SURGERY ON (B)(6) 2014 BUT DID NOT REMOVE THE TWO GII QUICK ANCHORS PLUS WITH ORTHOCORD. THE SURGEON FLUSHED THE AREA ONLY. A CULTURE WAS DONE ON THE DRAINAGE AND THIS CAME BACK AS GRAM NEGATIVE RODS. AT THIS TIME THE SALES REP HAS NO FURTHER INFORMATION REGARDING THE PATIENT STATUS. THE SALES REP REPORTED THAT THE ORIGINAL PROCEDURE WENT WELL WITH NO COMPLICATION OR DELAYS. SEE ASSOCIATED MEDWATCH 1221934-2014-00466.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT POST OP OF AN OPEN RIGHT ELBOW REPAIR THAT THE PATIENT'S INCISION STARTED DRAINING. THE SURGEON DID A FOLLOW-UP SURGERY ON (B)(6) 2014 BUT DID NOT REMOVE THE TWO GII QUICK ANCHORS PLUS WITH ORTHOCORD. THE SURGEON FLUSHED THE AREA ONLY. A CULTURE WAS DONE ON THE DRAINAGE AND THIS CAME BACK AS GRAM NEGATIVE RODS. AT THIS TIME THE SALES REP HAS NO FURTHER INFORMATION REGARDING THE PATIENT STATUS. THE SALES REP REPORTED THAT THE ORIGINAL PROCEDURE WENT WELL WITH NO COMPLICATION OR DELAYS. SEE ASSOCIATED MEDWATCH 1221934-2014-00466.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682322 GII QA+ W #2 ORTHOCORD MITEK NON ABSORBABLE ANCHOR IMPLANT JDR DEPUY MITEK NA 3726921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R