BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIXADVPEEK3SUTANC PCORD

    MDR report key: 8209841 · Received January 2, 2019

    Report

    Report Number
    1221934-2019-55887
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 28, 2018
    Report Date
    December 29, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705024759
    PMA / PMN Number
    K133794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART#: 223135 LOT#: L964406 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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 · 1

    IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE OUTER TIP ON THE 4.5 HEALIX ADVANCE PEEK THREE-SUTURE ANCHOR DEVICE FRACTURED (BROKE) DURING INSERTION. THE SALES REP STATED THAT FRAGMENTS WERE CREATED AND REMOVED EASILY WITHOUT ADDITIONAL SURGICAL INTERVENTION. THE CASE WAS COMPLETED WITH NO PATIENT HARM OR TIME DELAY USING THE SAME BONE HOLE. THERE WERE NO PROCEDURAL FACTORS THAT CONTRIBUTED TO THE EVENT BUT POTENTIAL HARD BONE WAS A FACTOR. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247 4.5 HEALIXADVPEEK3SUTANC PCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MAI DEPUY MITEK LLC US L964406 10886705024759

    Patients

    Seq Age Sex Outcome Treatment
    1