BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA 360 PATIENT POSITIONING SYSTEM

    MDR report key: 5992752 · Received October 1, 2016

    Report

    Report Number
    3004608878-2016-00260
    Event Type
    Malfunction
    Date Received
    October 1, 2016
    Report Date
    September 8, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 31 OCT 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: ENGINEERING AND REPAIRS WERE NOT ABLE TO CONFIRM THE CUSTOMER COMPLAINT. DURING A FUNCTIONAL REVIEW OF THE CUSTOMER COMPLAINT THE UNIT WAS DETERMINED THAT THE STANDARD ADAPTOR FUNCTIONS PROPERLY FOR FREEDOM OF MOVEMENT WHEN UNLOCKED AND LOCKS PROPERLY (RED CIRCLE BELOW). DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID UNDER LOT CODE/WORK ORDER 161/(B)(4) MANUFACTURED ON 02/27/16 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. A TOTAL 14 UNITS WERE BUILT AND THEY ALL PASSED THE 1101 INSPECTION CHECKLIST 100% QUANTITY. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. A TWO YEAR LOOKBACK IN TRACKWISE FOR THIS REPORTED FAILURE AND OR RELATED TO "VERY LOOSE WHEN ATTACHING TO UPPER HANDLE ASSEMBLY" FOR THIS PRODUCT ID SHOWS THAT 2 COMPLAINTS WERE RECEIVED INCLUDING BOTH WERE REPORTED BY THE SAME CUSTOMER ON SAME DATE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: ENGINEERING AND REPAIRS WERE NOT ABLE TO CONFIRM THE CUSTOMER COMPLAINT. THEREFORE NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME DISTRIBUTOR, SAME PRODUCT ID, SAME LOT NUMBER, DIFFERENT SERIAL NUMBERS, SAME PRODUCT PROBLEM). LINKEND TO MFG REPORT: 3004608878-2016-00261. DURING A PRODUCT INSPECTION THE CUSTOMER FOUND THAT THE A2009 ULTRA 360 PATIENT POSITIONING SYSTEM WAS VERY LOOSE. SPECIFICALLY THE STANDARD ADAPTOR (MARKED WITH A NUMBER 137). IT WAS VERY LOOSE WHEN ATTACHING IT TO BOTH SETS OF THE UPPER HANDLE ASSEMBLY DURING THE SITUATION OF UNLOCK. THE OTHER STANDARD ADAPTOR FROM ANOTHER SET DID NOT HAVE THE SAME PROBLEM. IT WAS SUSPECTED THAT SOMETHING WAS WRONG WITH THE BALL DETENTS FOR THE FAULTY ADAPTOR. THERE WAS NOT PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643851 ULTRA 360 PATIENT POSITIONING SYSTEM BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA 138991/161

    Patients

    Seq Age Sex Outcome Treatment
    1