BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SPACER BLOCK

    MDR report key: 6112509 · Received November 18, 2016

    Report

    Report Number
    1818910-2016-31741
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 5, 2016
    Report Date
    December 2, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.(B)(4).IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES A PIECE OF ONE OF THE BAL SEAL SPRING RETAINING LUGS HAS SNAPPED OFF. ALSO ONE OF THE SMALL BAL SEAL SPRINGS IS DAMAGED. THE INVESTIGATION CONFIRMED THE FAILURE MODE AS REPORTED. CARE NEEDS TO BE USED WHEN ASSEMBLING THESE CONNECTIONS, AS DAMAGE MAY OCCUR RESULTING IN THE TYPE OF FAILURE SEEN HERE. HOWEVER, THERE IS INSUFFICIENT INFORMATION SUPPLIED WITH THIS COMPLAINT TO DETERMINE WHETHER SUFFICIENT CARE WAS OR WAS NOT TAKEN. IT SHOULD BE NOTED THAT PRA 103033579 WAS RELEASED ON 08 JUL 2014 IN WHICH THE DAMAGE TO THE BALSEALS WAS EVALUATED. THE PRA CONCLUDED THAT THERE IS NO PATIENT HARM AS NONE OF THE FAILURE MODES HAVE LED TO ANY PATIENT HARM. FURTHERMORE, THE ASSEMBLY AND DISASSEMBLY OF THIS DEVICE IS CARRIED OUT BY THE SCRUB NURSE ON A TABLE AWAY FROM THE JOINT SPACE, ADDITIONALLY THE DEVICE CANNOT BE DISASSEMBLED WITHIN THE JOINT SPACE. IT SHOULD ALSO BE NOTED THAT THIS ISSUE WILL BE FURTHER MONITORED IN POST MARKET SURVEILLANCE THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND ENTERED INTO THE COMPLAINTS SYSTEM AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    A PIECE OF ONE OF THE BAL SEAL SPRING RETAINING LUGS HAS SNAPPED OFF. ALSO ONE OF THE SMALL BAL SEAL SPRINGS IS DAMAGED. KIT WAS USED FOR DEMO ONLY, HENCE NO PROCEDURE DATE. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION.

    Description of Event or Problem · 1

    A PIECE OF ONE OF THE BAL SEAL SPRING RETAINING LUGS HAS SNAPPED OFF. ALSO ONE OF THE SMALL BAL SEAL SPRINGS IS DAMAGED. KIT WAS USED FOR DEMO ONLY, HENCE NO PROCEDURE DATE. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. THE INSTRUMENT HAD FURTHER BEEN ASSESSED BY DEPUY ENGINEERING. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763255 ATTUNE SPACER BLOCK KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. BFA0VPS

    Patients

    Seq Age Sex Outcome Treatment
    1