BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGHT ACCESS TUBE 19MM X 50MM

    MDR report key: 4020873 · Received August 19, 2014

    Report

    Report Number
    9680938-2014-10052
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    July 24, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A 19MM X 50MM INSIGHT ACCESS TUBE (03.615.195 LOT T939232) WAS RECEIVED WITH A CHIPPED AND GOUGED DISTAL END OF THE DEVICE. ADDITIONALLY THE PROXIMAL INTERIOR CIRCUMFERENCE OF THE TUBE SHOWS WORN COATING, EXPOSING THE METAL BENEATH. APPLICABLE DRAWINGS FOR THE ACCESS TUBE WERE REVIEWED. THE DRAWINGS CALLED OUT HE APPROPRIATE DIMENSIONS, MATERIALS AND FINISHING PROCESSES FOR A SUCCESSFUL DEVICE DESIGN. THE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. A NOTE IS PRESENT ON THE TUBE DRAWING WHICH STATES THAT THE TUBES ARE ¿(B)(4).¿ THE DEVICE WAS FOUND TO BE ADEQUATE FOR ITS INTENDED USE. THE CIRCUMFERENCE ON THE DISTAL END OF THE RETURNED TUBE HAS SMALL CHIPS AND NICKS, WHERE THE COATING HAS BEEN WORN THROUGH. THE COMPLAINT DESCRIPTION STATES THAT IT IS UNKNOWN IF THE DAMAGE OCCURRED AT STERILE PROCESSING, IN THE OPERATING ROOM OR INTRA-OPERATIVELY. AS THE SPECIFIC CIRCUMSTANCES AS TO THE CAUSE OF THE COMPLAINT CONDITION ARE NOT AVAILABLE, THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE DEVICE IS DAMAGED, SO THE COMPLAINT IS CONFIRMED. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. SPECIFIC DETAILS REGARDING THE TECHNIQUE USED/APPLICATION WHICH LED TO THE COMPLAINT CONDITION WERE NOT PROVIDED; AS SUCH THE ROOT CAUSE OF THE COMPLAINT CONDITION COULD NOT BE IDENTIFIED. AS THE INSTRUMENT IS DAMAGED, THE COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT #00073013 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING BETWEEN 45 HRC AND WAS FOUND TO BE GOOD. NO NCRS WERE GENERATED DURING PRODUCTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6) REPORTED THE FOLLOWING EVENT: THE ENDS OF TWO INSIGHT TUBES WERE BENT AND BROKEN. IT IS NOT KNOWN IF THE DEVICES WERE FOUND BROKEN IN STERILE PROCESSING, OR THE OPERATING ROOM, OR IF THEY BROKE INTRAOPERATIVELY. THE EXTREMITY OF THE TUB THAT GOES IN THE PATIENT BENT AND BROKE OFF DESPITE NORMAL UTILIZATION. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF INJURY TO THE PATIENT AND NO REPORT OF A SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497401 INSIGHT ACCESS TUBE 19MM X 50MM RETRACTOR GAD SYNTHES TUTTLINGEN T939232

    Patients

    Seq Age Sex Outcome Treatment
    1