BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 5107584 · Received September 28, 2015

    Report

    Report Number
    3003875359-2015-10418
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 16, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: DECEMBER 23, 2013 NO NON-CONFORMANCE REPORTS 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. DEVICE 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: MANUFACTURING INVESTIGATION EVALUATION: RECEIVED ONE (1) ZIP-FIX INSTRUMENT (PART 03.501.080) FOR MANUFACTURING INVESTIGATION. THE SPRING MECHANISM IS BENT UPWARD. AFFECTED PART - PART 03.501.080 / LOT 8780300 THE COMPONENT SPRING STOP RIGHT CPL FROM ZIPFIX INSTRUMENT IS BENT. THE OPERATION LEVER JAMMED DURING OPERATION. A FUNCTIONAL TEST COULD NOT BE PERFORMED BECAUSE THE ZIPFIX INSTRUMENT NO LONGER FUNCTIONS. A MISHANDLING CANNOT BE EXCLUDED AS THE INSTRUMENT ORIGINALLY PASSED THE FUNCTIONAL TESTS AT THE ASSEMBLING STEP DURING THE MANUFACTURING PROCESS. THEREFORE, THE DEFORMATION WAS CAUSED POST-MANUFACTURING. THE COMPLAINT IS CONFIRMED, BUT NOT MANUFACTURING RELATED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED OR CONFIRMED. DEVICE 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(6). 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 TWO APPLICATION INSTRUMENTS FOR STERNAL ZIPFIX MALFUNCTIONED DURING A SURGICAL PROCEDURE ON (B)(6), 2015. THE CUTTER OF ONE APPLICATION INSTRUMENT IS NOT WORKING PROPERLY; THE TRIGGER OF THE OTHER APPLICATION INSTRUMENT IS JAMMING. THE PROCEDURE WAS PROLONGED BY FIFTEEN (15) MINUTES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639035 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 8780300

    Patients

    Seq Age Sex Outcome Treatment
    1