BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD

    MDR report key: 8942652 · Received August 28, 2019

    Report

    Report Number
    1221934-2019-58147
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 1, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007578
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODES: HTY, JDR; MBI; HWC INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE DISTAL TIP OF THE ANCHOR IS BROKEN, BUT IS HELD IN PLACE BY SUTURE. WHEN OBSERVED UNDER MAGNIFICATION, NO STRUCTURAL ANOMALIES WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THIS FAILURE. ANCHOR BREAKAGES ARE TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE ATTRIBUTED TO USER MISHANDLING OF THE DEVICE. HOWEVER, FROM THE GIVEN INFORMATION THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO NON CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 08/05/2019. 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: LOT NO NON CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 08/05/2019. UDI #: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE DISTAL TIP OF THE CUSTOMER'S 5.5MM HEALIX PEEK ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SALES REP STATED THAT THE SURGEON WAS OFF AXIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASEE. THE SALES REP STATED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE PATIENT'S BONE QUALITY WAS AVERAGE. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736765 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 222209 2L44386 10886705007578

    Patients

    Seq Age Sex Outcome Treatment
    1