BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX 5.5 AWL/TAP

    MDR report key: 16565217 · Received March 17, 2023

    Report

    Report Number
    1221934-2023-01242
    Event Type
    Injury
    Date Received
    March 17, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705007714
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT FILE WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. THE JOURNAL ARTICLE REVIEW INDICATED DEPUY MITEK PRODUCT FAILURE(S). MULTIPLE ATTEMPTS WERE DONE TO OBTAIN MORE INFORMATION FROM THE AUTHOR; HOWEVER, NO RESPONSE WAS RECEIVED. IT IS UNKNOWN IF COMPLAINTS DERIVED FROM THIS JOURNAL ARTICLE WERE PREVIOUSLY REPORTED AND DOCUMENTED IN THE DEPUY MITEK COMPLAINT SYSTEM AT THE TIME OF OCCURRENCE AS NO LOT NUMBER INFORMATION WAS PROVIDED TO PERFORM THE SEARCH. SINCE NO LOT NUMBER WAS PROVIDED, A MANUFACTURING RECORD EVALUATION OR STERILE LOAD REVIEW COULD NOT BE CONDUCTED. 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. UDI: (B)(4). THE LOT NUMBER WAS UNKNOWN. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE EXPIRATION DATE, MANUFACTURING SITE NAME AND DEVICE MANUFACTURE DATE WERE UNKNOWN. 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 FILE IS A REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ORLETSKII, A., ET AL (2022) SURGICAL TREATMENT OF POST-TRAUMATIC INSTABILITY OF THE SHOULDER JOINT IN ATHLETES. N. N. PRIOROV HERALD OF TRAUMATIC SURGERY AND ORTHOPEDICS, VOL. 29, NO. 1, PAGES 5-18 (RUSSIA). THE STUDY EMPHASIZES ON THE ASSESSMENT OF RESULTS AND COMPLICATIONS DURING THE POSTOPERATIVE PERIOD, SURGICAL INTERVENTION TIME, AND TECHNICAL DIFFICULTIES AND NUANCES DURING THE PERFORMANCE OF THE ARTHROSCOPIC LATARJET PROCEDURE AMONG PROFESSIONAL ATHLETES AND AMATEUR ATHLETES WITH POST-TRAUMATIC SHOULDER JOINT DEFECTS. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: 50 PATIENTS . THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ARTHROSCOPIC LATARJET PROCEDURE. THE DEVICES INVOLVED WERE: HEALIX 5.5 AWL/TAP. COMPLICATIONS DESCRIBED: 1 UNKNOWN PATIENT EXPERIENCED AXILLARY NERVE INJURY, WHICH RESOLVED AFTER 3 WEEKS OF ADDITIONAL TREATMENT. 1 PATIENT EXPERIENCED RECURRENT DISLOCATION. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548123 HEALIX 5.5 AWL/TAP BONE AWL LXH DEPUY MITEK LLC US 222224 10886705007714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention