BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE BR3SUT W/OC

    MDR report key: 7899700 · Received September 21, 2018

    Report

    Report Number
    1221934-2018-54714
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 23, 2018
    Report Date
    August 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021321
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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 DISCARDED BY THE CUSTOMER, THEREFORE, THE DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION NOR WERE PICTURES PROVIDED. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED. THE INITIAL FEEDBACK FROM THE SALES REPRESENTATIVE STATED THAT THE IMPLANT BROKE DURING INSERTION. NO FURTHER PROCEDURE INFORMATION WAS PROVIDED TO DETERMINE IF THE ABOVE REASON CONTRIBUTED TO THIS FAILURE. FURTHERMORE, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART 222296, WITH LOT L883020 COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN THE FUTURE, THIS FILE WILL BE RE-OPENED, AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S 4.5 HEALIX ADVANCE 3 SUTURE ANCHOR WITH ORTHOCORD BROKE WHILE BEING INSERTED. THE SALES REP STATED THAT HE DID NOT KNOW WHERE THE IMPLANT BROKE, IF THE SAME BONE HOLE WAS USED TO COMPLETE THE CASE, OR IF THE PATIENT HAD ANY ABNORMAL BONE DENSITY. THE SALES REP STATED THAT THE IMPLANT WAS REMOVED WITH NO FRAGMENTS LEFT IN THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738253 4.5 HEALIX ADVANCE BR3SUT W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L883020 10886705021321

    Patients

    Seq Age Sex Outcome Treatment
    1