BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 4806590 · Received May 29, 2015

    Report

    Report Number
    3003875359-2015-10236
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 03.501.080, APPLICATION INSTRUMENT FOR STERNAL ZIPFIX, LOT NUMBER 3822332). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT ¿WILL NOT TENSION/TIGHTEN.¿ THE SUBJECT DEVICE IS A FIRST GENERATION INSTRUMENT AND WAS RECEIVED WITH NO COMPONENTS, SCREWS OR NUTS LOOSE OR MISSING. THE PRODUCT DEVELOPMENT INVESTIGATION INCLUDED VISUAL INSPECTION, DESIGN EVALUATION AND FUNCTIONAL TESTING. THE PERFORMED HANDLING TEST BY PRODUCT DEVELOPMENT ON THE RETURNED INSTRUMENT WITH THREE IMPLANTS ON A STERNUM BONE MODEL SHOWED NO FUNCTIONAL DEFICIENCIES IN TENSIONING AND/OR CUTTING THE IMPLANTS WITH THE INSTRUMENT. THE TENSION APPLIED IS AS PER THE DESIGN INTENT. NO DAMAGES OR FUNCTIONAL ISSUES WERE IDENTIFIED. THERE ARE NO FUNCTIONAL OR DESIGN-RELATED ISSUES IDENTIFIED FOR THE RETURNED INSTRUMENT. THE COMPLAINT CONDITION WAS NOT CONFIRMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: UNKNOWN WHEN THE DEVICE STOPPED WORKING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24.JUN.2011, NO NCRS WERE GENERATED DURING PRODUCTION. 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

    IT WAS REPORTED THAT TWO ZIP FIX APPLICATION INSTRUMENTS DID NOT LOCK. IT WAS ALSO REPORTED THAT 3 DEVICES WOULD NOT TENSION/TIGHTEN AND THAT THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348537 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 3822332

    Patients

    Seq Age Sex Outcome Treatment
    1