BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX TI ANCHOR W/OCORD

    MDR report key: 9113432 · Received September 24, 2019

    Report

    Report Number
    1221934-2019-58493
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 26, 2019
    Report Date
    August 27, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705007998
    PMA / PMN Number
    K082282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT IS STILL IMPLANTED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222253, LOT #L790057 COMBINATION 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: NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON (B)(6)2019. 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 · 1

    PRODUCT COMPLAINT # (B)(4). 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A SHOULDER ARTHROSCOPY A 4.5 HEALIX TI ANCHOR W/OCORD WAS PLACED IN THE BONE, AFTER THAT THE SPECIALIST USED THE ORTHOCORD SUTURE STRANDS TO REPAIR THE SUBSCAPULARIS MUSCLE. WHILE KNOTTING AND GENERATING TRACTION TO THE VIOLET THREAD, IT BROKE. THE TRACTION EXERTED ON THE THREAD WAS MINIMAL AND NO DETERIORATION OF THE STRAND WAS OBSERVED BY MANIPULATION. THE REPAIR COULD BE DONE WITH THE REMAINING SUTURE THREAD. THE SURGERY WAS EXTENDED 10 MINUTES DUE TO THE INCIDENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904745 4.5 HEALIX TI ANCHOR W/OCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US L790057 10886705007998

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR