BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 4945173 · Received July 24, 2015

    Report

    Report Number
    3004608878-2015-00204
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    June 30, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015: METHODS: EVALUATION OF ACTUAL DEVICE. DEVICE HISTORY REVIEW. COMPLAINTS HISTORY REVIEW. RESULTS: ENGINEERING AND REPAIRS WERE ABLE TO CONFIRM THE CUSTOMER COMPLAINT. UPON INSPECTION, THE CASTING OF THE BASE HANDLE ASSEMBLY (41A1498) WAS CRACKED AT THE SHOCK CUSHION SLOTTED AREA. THE DHR REVIEW FOR ITEMS WITH LOT CODE 114 (MANUFACTURED ON THE SECOND QUARTER OF 2014) SHOWS THAT THE FOLLOWING LOTS PASSED ALL NECESSARY INSPECTION POINTS WITH NO MRR, REWORKS OR VARIANCES. NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND NOR WHERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH THIS LOT/WORK ORDER NUMBER. A TWO YEARS COMPLAINTS HISTORY REVIEW FOR THE REPORTED FAILURE AND FOR THIS PRODUCT ID SHOWS THAT 4 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: A2101 LOT CODE 114 DEVICE WAS RECEIVED FROM THIS CUSTOMER AS SUCH ENGINEERING AND REPAIRS WERE ABLE TO VERIFY THE CUSTOMER COMPLAINT. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THERE IS A CHANCE THAT IT COULD BE A COMBINATION OF WEAR AND TEAR AND CLAMPING THE LEVER DOWN IN THE HANDLE CONTINUOUSLY.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PRODUCT ID, SAME PRODUCT PROBLEM SAME USER FACILITY, DIFFERENT PRODUCT LOT CODES). ITEM WAS IDENTIFIED AS CRACKED. THE PRODUCT WAS NOT IN CONTACT WITH THE PATIENT AND THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT DID NOT LEAD TO AN INCREASE IN SURGERY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484244 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1