BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 HEALIX TI ANCHOR W/OCORD

    MDR report key: 8873841 · Received August 8, 2019

    Report

    Report Number
    1221934-2019-57929
    Event Type
    Injury
    Date Received
    August 8, 2019
    Report Date
    July 3, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MBI
    PMA / PMN Number
    K082282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: D2 ADDITIONAL PROCODES: JDR, HWC D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

    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. THE COMPLAINT DEVICE IS NOT BEING RETURNED, MULTIPLES ATTEMPTS FOR PRODUCT RETURN WERE MADE WITH NO RESPONSE, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [L954316] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. DEVICE HISTORY THE BATCH REVIEW L954316 SHOWED THAT THE 299 DEVICES WERE CONFORMED TO IN PROCESS AND FINISHED GOODS SPECIFICATIONS WHEN RELEASED TO STOCK ON AUGUST 9TH 2018. EXPIRATION DATE: JUNE 30TH 2021 (ACCORDING TO RETAINED LABELS). NO NC WAS OPENED. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ADDITIONAL INFORMATION: (B5) - EVENT DESCRIPTION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED STATED THIS ALLEGED DEVICE MALFUNCTION WAS REPORTED UNDER A SINGLE COMPLAINT. IT WAS LATER REPORTED BY THE AFFILIATE THAT PRODUCT AND LOT CODES ARE UNAVAILABLE AT THIS TIME. IT WAS REPORTED THIS EVENT OCCURRED AFTER A ROTATOR CUFF REPAIR PROCEDURE AND A REVISION SURGERY WAS REQUIRED TO REMOVE THE BROKEN ANCHOR FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 AFFILIATE VIA EMAIL THAT ONE OF THE SURGEON REPORTED A COMPLICATION REGARDING HEALIX ANCHORS. THE SURGEON STATES HE HAD TWO PATIENTS LAST YEAR WHO HAVE HAD A SINGLE HEALIX ANCHOR USED FOR ROTATOR CUFF REPAIR. IN THESE TWO PATIENTS THE HEALIX ANCHOR HAS COME AWAY FROM THE BONE AND IN ONE INSTANCE, BEEN FOUND ABOUT TWO THIRDS OF THE WAY PROTRUDING FROM THE BONE CAUSING SYMPTOMS AND IN THE OTHER, FREE IN THE SUBACROMIAL SPACE. IN THE FIRST PATIENT THE ROTATOR CUFF HAD ACTUALLY HEALED AND THE SECOND PATIENT HAS BEEN SEND FOR A SCAN TO DETERMINE THE INTEGRITY OF HIS REPAIR BUT THE ANCHOR IS DUE FOR REMOVAL LATER THIS MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667821 4.5 HEALIX TI ANCHOR W/OCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI DEPUY MITEK LLC US L954316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention