BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 5727904 · Received June 15, 2016

    Report

    Report Number
    2523190-2016-00089
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 26, 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

    ON 8/7/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: PER THE RECEIVED 4020 WISHBONE ASSEMBLY, THE DEFECTIVE UNIT FAILED MANUFACTURING CHECKS 1, 2II AND 3 . DURING EVALUATION, ENGINEERING REGISTERED A HANDLE THROW FORCE OF 31 LBS. WHICH IS CONSIDERABLY ABOVE THE RECOMMENDED RANGE OF 8-15 LBS. THE 4020 WISHBONE ARMS FAILED THE ROTATIONAL RESISTANCE FUNCTIONAL CHECK WITH ACCOMPANYING RESISTANCE, GRINDING AND SQUEAKING NOISE AS WELL. FURTHERMORE ENGINEERING OBSERVED MINIMAL GRINDING AS THE TAPER JOINT WAS BEING ROTATED PER MANUFACTURING CHECK 3. THERE IS CONSIDERABLE AMOUNT OF WEAR AND TEAR PRESENT ON THE SURFACES OF BOTH RECEIVED DEFECTIVE UNITS. THIS IS NORMAL WEAR AND TEAR EXPECTED FROM REGULAR USAGE OVER TIME. DEVICE HISTORY EVALUATION: DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID UNDER LOT CODE 157 SHOWS NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THESE DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. CONCLUSION: IN REGARDS TO THE 4020 WISHBONE ASSEMBLY, THE DEFECTIVE UNIT IS BEING RETURNED FOR THE THIRD TIME WITH PREVIOUS SERVICING PERFORMED ONLY ONCE . THE UNIT DID NOT REQUIRE ANY FURTHER SERVICING. 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 OVERTIGHTENED YET THERE AREN¿T ANY SIGNS INDICATING THE 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

    DOCTOR INITIALLY REPORTS THAT CAM LEVER LOCK ON STERILE FIELD POST IS TOO EASY TO ENGAGE AND NOT HOLDING WISH BONE IN PLACE. ON (B)(6) 2016 CUSTOMER REPORTS THAT THE SURGEON WAS PERFORMING AN ANTERIOR SPINAL DISCECTOMY WITH FUSION WHEN SOON INTO THE PROCEDURE THE DEVICE FAILED TO HOLD POSITION. NO HARM DONE CONFIRMED. NUMBER 2 OF 2 RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380628 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1