BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 5807095 · Received July 19, 2016

    Report

    Report Number
    2523190-2016-00116
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Report Date
    June 28, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 1ST, 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; THE RECEIVED UNIT IS NOW EXHIBITING SIGNS OF EXCESSIVE RESISTANCE DURING THE HANDLE THROW MOTION AND THE ROTATIONAL RESISTANCE OF THE WISHBONE ARMS THROUGH THEIR ENTIRE RANGE. DHR REVIEW; DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID UNDER LOT CODE 157 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THESE DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK COMPLAINTS HISTORY; A TWO YEAR LOOKBACK FOR THIS REPORTED FAILURE AND OR RELATED TO " LOOSE ON LARGER PATIENTS DURING SURGERY, PARTS NOT READILY AVAILABLE AND LOANERS NOT AVAILABLE FOR THIS PRODUCT FAMILY" FOR THIS PRODUCT ID SHOWS THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: THE DEFECTIVE UNIT IS BEING RETURNED FOR THE THIRD TIME. THE RECEIVED UNIT IS NOW EXHIBITING SIGNS OF EXCESSIVE RESISTANCE DURING THE HANDLE THROW MOTION AND THE ROTATIONAL RESISTANCE OF THE WISHBONE ARMS THROUGH THEIR ENTIRE RANGE. THE ROOT CAUSE FOR THE OBSERVED FAILURE CANNOT BE FULLY DETERMINED. THE UNIT DEMONSTRATES SIGNS OF BEING OVER TIGHTENED YET THERE AREN¿T ANY SIGNS INDICATING THE 4032011 NUT BEING TAMPERED WITH WHILE OUT IN THE FIELD. FURTHERMORE, THE UNIT WAS COMPLETELY DISASSEMBLED WITH NO SIGNS OF INTERNAL COMPONENT DEFORMATIONS WHICH COULD BE IDENTIFIED AS A CONTRIBUTING FACTOR TO THE OBSERVED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPLAINT WAS ORIGINALLY TO FIX A RETRACTOR THAT WAS BECOMING LOOSE ON LARGER PATIENTS DURING SURGERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459700 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 157

    Patients

    Seq Age Sex Outcome Treatment
    1