BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 7819945 · Received August 27, 2018

    Report

    Report Number
    1221934-2018-54547
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Report Date
    July 30, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. 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. UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED WITH NEW PRODUCT DEVELOPMENT (NPD). NPD WAS ABLE TO IDENTIFY THE DEVICE AS: HEALIX ADVANCE KNOTLESS HAK BR MATERIAL, PART NUMBER: 222331; ORIGINALLY THE PRODUCT CODE WAS UNKNOWN. VISUAL OBSERVATION REVEALED A CRACK RUNNING VERTICALLY ON THE DISTAL TIP AND THE BASE OF THE ANCHOR. DEVICE STILL IN ONE PIECE THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. BASED ON VISUAL OBSERVATION THE CONDITION OF THE DEVICE RECEIVED INDICATED THIS DEVICE WAS USED. SUTURE CARD AND SUTURE CARD COVER WERE MISSING. THE IMPLANT WAS OFF THE INSERTER SHAFT. BUT THE SUTURE WAS STILL ATTACHED TO THE IMPLANT, INDICATING THE SUTURE BRIDGE WAS STILL INTACT. POSSIBLE ROOT CAUSE FOR THE OBSERVED FAILURE COULD BE OFF AXIS INSERTION, HARD BONE QUALITY, LEVERING DURING INSERTION, OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. THE PATTERNS OF THE CRACK ON THE SCREW INDICATES POTENTIAL USE OF EXCESS TORSION DURING INSERTION, HOWEVER A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, NO LOT NUMBER WAS SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (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. UDI: UNAVAILABLE. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER ARE NOT AVAILABLE. THERE IS NO CATALOG NUMBER AND LOT NUMBER AVAILABLE, HENCE, PMA/ 510(K) AND PROCODE IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP, ONCE THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR WAS BROKEN WHEN OPENED DURING THE SURGERY (DATE OF THE SURGERY WAS UNKNOWN). THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662301 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR MAI DEPUY MITEK LLC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1