BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPPER FOR LISS INSERTION GUIDES

    MDR report key: 6383518 · Received March 7, 2017

    Report

    Report Number
    9612488-2017-10097
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Report Date
    February 10, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    UDI-DI
    07611819208322
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (STOPPER FOR LISS INSERTION GUIDES, PART NUMBER 324.019, LOT NUMBER 9012313). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: 1 X PART 324.019 / #LOT 9012313 / STOPPER F/LISS INSERTION GUIDE : THE EVALUATION OF THE STOPPER HAS SHOWN THAT THREE OUT OF THE FOUR PRONGS ARE BROKEN OFF AND A SMALL PIECE FROM THE LAST PRONG IS ALSO BROKEN. THE BROKEN PARTS WERE NOT RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE DUE THE DAMAGE. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN OCTOBER 2005 AND THIS IS ONLY OUR (B)(4) COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THIS AND THE USED CONDITION OF THE STOPPER LET US EXCLUDE A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE. WE CAN ONLY ASSUME THAT TOO MUCH LATERAL FORCE WAS APPLIED WHEN THE STOPPER WAS PUT-ON THE HOLDING PIN OF THE VARIO CASE, BECAUSE SUCH A BREAKAGE IS NORMALLY NOT POSSIBLE WHEN THE STOPPER IS INSERTED INTO A HOLE OF THE INSERTION GUIDE. THE 324.019 / 9012313: BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE. WE CAN ONLY ASSUME THAT TOO MUCH LATERAL FORCE WAS APPLIED WHEN THE STOPPER WAS PUT-ON THE HOLDING PIN OF THE VARIO CASE, BECAUSE SUCH A BREAKAGE IS NORMALLY NOT POSSIBLE WHEN THE STOPPER IS INSERTED INTO A HOLE OF THE INSERTION GUIDE. 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

    ADDITIONAL NARRATIVE: THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 324.019, LOT # 9012313: THIS PART WAS MANUFACTURED UNDER THE INTERNAL PART NUMBER 42999, THIS NUMBER IS ALSO LISTED ON THE DRAWING UNDER THE EXTERNAL PART NUMBER 324.019. THEREFORE THE DHR REVIEW WAS MADE FOR PART 42999 LOT 9012313: MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 14-OCTOBER-2005. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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 DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING CLEANING PROCESS IT WAS DISCOVERED THAT THE STOPPER AND THE DRILL BIT WERE BROKEN. IT IS UNKNOWN WHERE THE DEVICES BROKE. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165881 STOPPER FOR LISS INSERTION GUIDES GUIDE FZX SYNTHES BETTLACH 9012313 07611819208322

    Patients

    Seq Age Sex Outcome Treatment
    1