BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11.5/9 L178 F/AFN

    MDR report key: 4286106 · Received December 1, 2014

    Report

    Report Number
    9612488-2014-10545
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE 510K #: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA NO NONCONFORMANCE REPORTS 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: A MANUFACTURING EVALUATION WAS COMPLETED: ONE UNIT OF ARTICLE 356.706 STICKING IN A UNIT OF 356.705 HAS SCRATCH MARKS FROM MOVING INTO AND REMOVING FROM ARTICLE 356.705. BESIDES THIS ALL UNITS ARE CLEAN AND OPTICALLY UNDAMAGED. FOUR UNITS OF ARTICLE 356.705 AND FOUR UNITS OF ARTICLE 356.706 WERE RECEIVED. GENERALLY, THE UNITS OF ARTICLE 356.706 DO NOT FIT INTO ARTICLES 356.705. ALL UNITS ARE CLEAN. TWO UNITS OF ARTICLE 356.706 STICK IN A UNIT OF ARTICLE 356.705 EACH AND CANNOT BE SEPARATED ANYMORE. TWO UNITS OF ARTICLE 356.705, LOT 9129661, WERE RETURNED. THE UNITS WERE MEASURED, ALL PARAMETER FULFILLED THE REQUIREMENTS. IN ADDITION, ONE UNIT OF ARTICLE 356.705, LOT 9173028, WAS RETURNED AND ALSO CONFORMS TO THE SPECIFICATIONS. THE DIAMETER OF DRILL-HOLE 9MM (ARTICLE 356.705, LOT 9256363) WAS MEASURED AND ALSO CONFORMED TO THE SPECIFICATIONS. TAKE TOGETHER THESE RESULTS SHOW THAT ALL RELEVANT DIMENSIONS OF ARTICLE 356.705, WHICH ARE RELEVANT FOR THE COMPLAINT, FULFILL THE SPECIFICATIONS. THEREFORE THERE IS NO INDICATION THAT THE ROOT CAUSE OF THE COMPLAINT IS IN THE DESIGN OR THE MANUFACTURING OF THE ARTICLE. THE MEASUREMENTS PERFORMED ON ARTICLE 356.706 INDICATE THAT ONE DIMENSION RELEVANT FOR THE COMPLAINT DOES NOT FULFILL THE SPECIFICATIONS, WHICH IS MOST PROBABLY THE CAUSE OF THE COMPLAINT. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PRIOR TO SURGERY IT WAS DISCOVERED THE NEW SHIPMENT OF REPORTED DEVICES DO NOT FIT TOGETHER. OLD DEVICE WERE TRIED WITH THE NEW SHIPMENT AND THE OLD DEVICES ALSO DID NOT FIT WITH THE NEW DEVICES. NO PATIENT INVOLVED. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773737 PROTECT SLEEVE 11.5/9 L178 F/AFN GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES BETTLACH 9173028

    Patients

    Seq Age Sex Outcome Treatment
    1