BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.75 HEALIX ADVANCE KNTLS PEEK

    MDR report key: 11872358 · Received May 24, 2021

    Report

    Report Number
    1221934-2021-01638
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 11, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: BACKGROUND: INSERTER WAS PLACED ACCORDING TO SURGERY GUIDELINES. THEN 4.75 ANCHOR WAS PLACED BUT COULD NOT BE FIXED AND WAS REMOVED. 5.5 ANCHOR WAS USED, BUT ALSO COULD NOT BE FIXED. FINALLY, VERSALOK ANCHOR COULD BE PLACED IN AN ADDITIONAL HOLE. INVESTIGATION SUMMARY: THE 4.75 HEALIX ADVANCE KNTLS PEEK (PART #: 222888, LOT #: 7L47770) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE DEVICE WAS MISSING THE HEALIX ADVANCE KNOTLESS THREADER TAB, DOUBLE (PART #: 133983). SINCE THE DEVICE WAS RECEIVED INCOMPLETE, THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSE CAN BE ASSOCIATED WITH INCOMPLETE INSERTION WHICH MAY RESULT IN ANCHOR PULLOUT. HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. AS PER IFU-116046 (REV B), IT IS IMPORTANT TO ENSURE THAT THE ANCHOR IS INSERTED AXIALLY TO THE BONE HOLE (LIMIT OFF-AXIS INSERTION) AND THE AREA OF ANCHOR INSERTION MUST BE FREE OF SOFT TISSUE. ALSO, IMPROPER INSTRUMENT USE, AXIAL MISALIGNMENT, OR LEVERING WITH THE ANCHOR UPON INSERTION, MAY RESULT IN ANCHOR FRACTURE. AN MRE WAS REVIEWED, NO NON-CONFORMANCES WERE IDENTIFIED FOR THE REPORTED PART #: 222888, LOT #: 7L47770 COMBINATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.75 HEALIX ADVANCE KNTLS PEEK DEVICE COULD NOT BE FIXED AND THUS, WAS REMOVED. ANOTHER LIKE DEVICE WAS USED TO PLACE IN THE ADDITIONAL HOLE TO COMPLETE THE PROCEDURE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766144 4.75 HEALIX ADVANCE KNTLS PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 7L47770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention