BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCI S&N POW/POW MAX

    MDR report key: 7732482 · Received July 30, 2018

    Report

    Report Number
    1221934-2018-53353
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    January 5, 2015
    Report Date
    January 7, 2015
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION INDICATES THAT THE TWO JACK SCREWS DO NOT PROTRUDE FAR ENOUGH OUT OF THE CONNECTOR HOUSING WHICH WOULD NOT ALLOW IT TO CONNECT SECURELY TO THE MATING FASTENERS ON THE BACK OF THE PUMP. THIS WOULD CAUSE AN UNRELIABLE CONNECTION BETWEEN THE INTERFACE AND THE PUMP. THIS COMPLAINT CAN BE CONFIRMED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED FOR THIS LOT OF (B)(4) PIECES THAT WERE MANUFACTURED IN 2012 AND THE RESULTS INDICATE THAT IN THIS BATCH OF PRODUCT THERE WERE NO ANOMALIES OR DISCREPANCIES IN THE MANUFACTURE OF THIS LOT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THE SERIAL NUMBER OF THIS DEVICE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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. ASSOCIATED MEDWATCH: 1221934-2018-53351.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE REPAIR THAT TWO OF THE CUSTOMER'S HAND CONTROL INTERFACES, POWER/POWER MAX, WERE WORKING ON AND OFF. THE SURGEON COMPLETED THE PROCEDURE WITH A 3RD LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574036 HCI S&N POW/POW MAX LINE-POWERED SHAVER SYSTEM HANDPIECE ELECTRICAL CABLE HRX DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1