BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5HLX ADV BR ANC-DYNA 3-SUT

    MDR report key: 17573895 · Received August 18, 2023

    Report

    Report Number
    1221934-2023-03127
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    March 2, 2023
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705029396
    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 FILED AS APPROPRIATE. 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. 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.

    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. 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED; THE AVAILABILITY OF THE DEVICE IS UNKNOWN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THERE WAS NO CONTACT INFORMATION, NO FOLLOW-UP ATTEMPTS COULD BE PERFORMED. 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 (9L62952), 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT ON (B)(6) 2023, A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON THE LEFT SHOULDER WITH BICEPS TENODESIS, ARTHROSCOPIC SUBACROMIAL DECOMPRESSION AND ACROMIOPLASTY, ARTHROSCOPIC DEBRIDEMENT OF THE GLENOID LABRUM AND ARTHROSCOPIC LEFT DISTAL CLAVICLE RESECTION (MUMFORD TYPE) USING A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. ACCORDING TO THE REPORT, A RE-OPERATION/REVISION WAS PERFORMED ON (B)(6) 2023 AS THE PATIENT DEVELOPED AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127269 4.5HLX ADV BR ANC-DYNA 3-SUT FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI MEDOS INTERNATIONAL SàRL 9L62952 10886705029396

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention