BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11.5/9 L178 F/AFN

    MDR report key: 4341028 · Received December 18, 2014

    Report

    Report Number
    9612488-2014-10570
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT/EXPLANT DATE UNKNOWN. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED. 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. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVIC; THE TWO PARTS WERE STUCK TOGETHER AND COULD NOT BE SEPARATED BY HAND. SCRATCHES FROM USE WERE VISIBLE. ONE UNIT OF ARTICLE 356.705, LOT 925636, AND ONE UNIT OF 356.706, LOT 9236522 WERE RETURNED. THE TWO PARTS WERE STUCK TOGETHER AND COULD NOT BE SEPARATED BY HAND. SCRATCHES FROM USE WERE VISIBLE. THE TWO UNITS OF THIS COMPLAINT WERE MEASURED FOR THE RELEVANT DIMENSIONS WITH THE RESULT, THAT THE DIAMETER 9-H6 OF ARTICLE 356.706 WAS ABOVE SPECIFICATION. ALL OTHER DIMENSIONS MEASURED AND FULFILLED THE SPECIFICATIONS. SINCE THE TWO PARTS COULD ONLY BE SEPARATED APPLYING STRONG MECHANICAL FORCES, THE ARTICLE 356.705 WAS DAMAGED IN A WAY THAT THE INNER DIAMETER COULD NOT BE DETERMINED ANYMORE. THE COMPLAINT IS CONFIRMED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SLEEVES DO NOT FIT AND WERE TRIED FROM BOTH SIDES. THE EVENT OCCURRED IN THE WAREHOUSE, NO PATIENT INVOLVEMENT. THIS WAS THE THIRD TIME THAT THIS EVENT HAS TAKEN PLACE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831143 PROTECT SLEEVE 11.5/9 L178 F/AFN GUIDE FZX SYNTHES BETTLACH 9256363

    Patients

    Seq Age Sex Outcome Treatment
    1