BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 5837366 · Received August 1, 2016

    Report

    Report Number
    9612007-2016-00021
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 21, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DEVICE UNATTENDED

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12 SEP 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: AN IP1P LOT 290316 WAS RECEIVED WITH A BROKEN ADJUSTABLE STOP OF IP1 LOT 030216. THE COMPONENT BROKE AT THE AREA WHERE THE SETSCREW IS SITUATED. VISUAL INSPECTION REVEALS THE COMPONENT IS SLIGHTLY MORE ¿COLORED¿ (SLIGHTLY BROWN) WHEN COMPARED WITH A COMPONENT FROM INVENTORY OR A COMPONENT USED FOR THE DESIGN VERIFICATION. THE DEVICE HISTORY RECORDS (INCLUDING STERILIZATION) OF IP1 LOT 290316 AND IP1 LOT 030216 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE IP1 BATCH (WHICH INCLUDES THE BROKEN COMPONENT) INCLUDED (B)(4) PRODUCTS AND WAS MANUFACTURED IN FEBRUARY 2016. IT WAS MANUFACTURED WITH THE ADJUSTABLE STOP COMPONENT REF B280014, LOT 160715: REVIEW OF INCOMING INSPECTION RECORDS DID NOT REVEAL ANY ANOMALY. THIS BATCH WAS RELEASED ON JULY 21, 2015 AND INCLUDED (B)(4) PIECES: (B)(4) PIECES HAVE ALREADY BEEN USED TO MANUFACTURE PRODUCTS. MODIFICATION OF SALES FIGURES AS OF SEPTEMBER 6, 2016: FROM JAN 1, 2013 TO AUGUST 30, 2016: (B)(4) UNITS OF IM1, IM1S, IP1, IP1P HAVE BEEN SOLD. COMPLAINT RATE IS (B)(4). CONCLUSION: THE COMPLAINT IS VERIFIED. TESTING ALREADY PERFORMED IN 2015 MADE ON (B)(4) PRODUCTS REPRODUCED THE BREAKAGE AND SHOWED SUCH ISSUE MAY BE RELATED TO THE STERILIZATION RADIATION DOSE AND/OR TO HIGH SCREWING FORCES (HIGHER THAN 0.7N/M). NO CORRECTIVE ACTION WAS DEEMED REQUIRED. GMS TESTING IS APPLICABLE TO THE PRESENT COMPLAINT. FOR THE TWO PREVIOUS CASES, THE REPORTED BREAKAGE OCCURRED DURING SCREWING OF THE ADJUSTABLE STOP, IT IS POSSIBLE THAT TOO HIGH SCREWING FORCE WAS USED.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF THREE REPORTS (SAME PRODUCT ID, SAME PRODUCT PROBLEM, SAME FACILITY). LINKED TO MFG REPORTS: 9612007-2016-00022 AND 9612007-2016-00023. THE IP1P WAS FOUND TO HAVE A BROKEN CLAMPING RING (JUST AFTER LITTLE SCREW TIGHTENING TURN) ON THE PROBE PTIO2. THE INCIDENT OCCURRED ON (B)(6) 2016 DURING A PROCEDURE ON A (B)(6) MALE PATIENT. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE PRODUCT PROBLEM. THE PROBLEM CAUSED A 20-30 MINUTE DELAY IN PROCEDURE. A REPLACEMENT DEVICE WAS AVAILABLE AND USED BY THE MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490457 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 030216

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR