BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX TRANSTEND BR/2 IMPL SYS

    MDR report key: 8258397 · Received January 17, 2019

    Report

    Report Number
    1221934-2018-51631
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705008094
    PMA / PMN Number
    K102298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE DISTAL TIP OF THE ANCHOR IS BROKEN, BUT IS STILL ATTACHED TO THE 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222263-LOT #3787587 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR IN THEIR HEALIX TRANSTEND IMPLANT SYSTEM (BR/2) BROKE DURING INSERTION. THE SALES REP STATED THAT THE ANCHOR BROKE A THIRD OF THE WAY UP. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN PIECES AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TWO MINUTE DELAY. THE SALES REP STATED THAT THE BONE QUALITY OF THE PATIENT WAS AVERAGE AND THAT THE PATIENT WAS A (B)(6) MALE SMOKER. THE DEVICE WILL BE RETURNING FOR EVALUATION. 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
    50060 HEALIX TRANSTEND BR/2 IMPL SYS SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US 3787587 10886705008094

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR