BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 8524781 · Received April 17, 2019

    Report

    Report Number
    1221934-2019-56877
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 26, 2019
    Report Date
    March 26, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    PMA / PMN Number
    K051989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED AS IT WAS IMPLANTED IN THE PATIENT, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (222983) - LOT NUMBER (2L44203) COMBINATION AS PER PER QLIK QUERY EXECUTED 04/10/2019. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ELBOW PROCEDURE THE GII QUICKANCHOR+ WITH #2 ORTHOCORD SUTURES WERE BEING TIED WHEN THE SUTURE BROKE AT THE EYELET. THE SALES REP STATED THAT THE ANCHOR WAS LEFT IN THE PATIENT AND THE NEW LIKE-ANCHOR WAS USED IN THE SAME BONE HOLE WITH THE OTHER ANCHOR TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS GOOD. THE ANCHOR IS NOT BEING RETURNED AS IT IS IMPLANTED IN THE PATIENT. FURTHER IT WAS REPORTED THAT THE SURGEON WAS TYING KNOT BY HAND. NO SUTURE PASSER WAS USED. IT PASSED WITH NEEDLE PROVIDED ON SUTURE. IT WAS ALSO REPORTED THAT NO CUTTER WAS USED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316645 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 2L44203 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention