BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR FOR CERCLAGE PASSER

    MDR report key: 6358178 · Received February 24, 2017

    Report

    Report Number
    9612488-2017-10073
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    December 14, 2016
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    UDI-DI
    07611819880061
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: NO PATIENT INVOLVEMENT. THE COMPLAINT OF SEPARATION WAS RECEIVED ON DEC 14, 2016. DURING THE INVESTIGATION COMPLETED ON JAN 26, 2017, IT WAS FOUND THAT THE DEVICE IS BROKEN. ADDITIONAL DEVICE PRODUCT CODE IS FSM. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28.SEP.2016. NO NON-CONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: TROCAR (03.221.003 / L133575). UPON VISUAL INSPECTION, THE WIRE OF THE TROCAR IS BROKEN DIRECTLY AFTER THE HANDLE. THE LASER MARKING WAS READABLE. THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, (B)(4) PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN SEPTEMBER 2016. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. MOREOVER A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE RAW MATERIAL CERTIFICATE WAS CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THE EXACT REASON FOR THIS OCCURRENCE COULD NOT BE DETERMINED. NO PRODUCT FAULT COULD BE DETECTED. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CHARGE NURSE WAS SHOWING STAFF MEMBERS HOW THE INSTRUMENT WORKED WHEN THE SHAFT OF THE TROCAR BECAME SEPARATED FROM THE HANDLE OF THE INSTRUMENT. IT IS A NEW INSTRUMENT AND HAD NOT YET BEEN STERILIZED FOR USE. NO ADVERSE EVENT. NO PATIENT INVOLVEMENT. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139082 TROCAR FOR CERCLAGE PASSER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BETTLACH L133575 07611819880061

    Patients

    Seq Age Sex Outcome Treatment
    1