BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX AV BR 5.5 TAPE WHT/BLUE

    MDR report key: 7948317 · Received October 9, 2018

    Report

    Report Number
    1221934-2018-54893
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 9, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705027828
    PMA / PMN Number
    K170639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

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

    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. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE DISTAL TIP OF THE ANCHOR IS BROKEN TRANSVERSELY, SEPARATED FROM THE INSERTER BUT IS HELD BY THE SUTURE. THE COMPLAINT CAN BE CONFIRMED. THE ANCHOR APPEARS NEW AND NO EVIDENCE OF ANY DEBRIS FOUND ON THE ANCHOR OR THE TIP OF THE SHAFT. THIS TYPE OF ANCHOR BREAKAGE IS CONSISTENT WITH BREAKAGE CAUSED BY THE COMBINATION OF TORQUE AND BENDING, A USER TECHNIQUE ISSUE BUT OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (222362), LOT (L570398) COMBINATION AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 VIA PHONE THAT DURING A ROTATOR CUFF REPAIR REVISION PROCEDURE THE CUSTOMER'S 5.5MM HEALIX ADVANCE ANCHOR WITH PERMATAPE, WHITE/BLUE BROKE JUST ABOVE THE THIRD THREAD ON THE DISTAL END. THE ANCHOR BROKE WHILE INSERTING AND THE PIECES ARE CONNECTED TOGETHER BY THE SUTURE. THE SALES REP STATED THAT THE PATIENT HAD A NORMAL BONE DENSITY AND THE SURGEON WAS INSERTING ON AXIS. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED USING THE SAME BONE HOLE WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE ANCHOR IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787293 HEALIX AV BR 5.5 TAPE WHT/BLUE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL L570398 10886705027828

    Patients

    Seq Age Sex Outcome Treatment
    1