BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK)

    MDR report key: 17400384 · Received July 26, 2023

    Report

    Report Number
    1221934-2023-02817
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    August 2, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705029457
    PMA / PMN Number
    K173859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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 FIED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (8L50360), AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: 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 · 0

    THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022 USING A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED SWELLING OF THE LEFT HAND ON (B)(6) 2022, LEFT ELBOW ¿ OLECRANON BURSITIS ON (B(6) 2022, RE-TEARS/NEW TEARS AND POSSIBLE UNDERLYING INFECTION ON (B)(6) 2022 AND ADHESIVE CAPSULITIS ON (B)(6) 2022. IT WAS REPORTED THAT THESE EVENTS DID NOT RESULT IN A REOPERATION/REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661434 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLU,WHT/BLU/GRN,WHT/BLK) FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI MEDOS INTERNATIONAL SàRL 8L50360 10886705029457

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention