BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 4242779 · Received November 11, 2014

    Report

    Report Number
    3003875359-2014-10365
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 16, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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

    THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE TWO SECOND GENERATION INSTRUMENT SHOWING LITTLE - TO NO MARKS ON THEIR MOVING PARTS WHICH INDICATES A SHORT TIME USE OF THE DEVICE. NO SCREWS ARE LOOSE OR OTHER DAMAGES ARE IDENTIFIED BOTH RETURNED INSTRUMENTS OF LOT NUMBERS: 8497301 AND 8520341 HAVE BEEN INSPECTED ON FUNCTIONALITY. NO ISSUE WAS IDENTIFIED. THE HANDLING TEST WITH EACH OF THE RETURNED INSTRUMENT AND THREE IMPLANTS WAS PREFORMED AFTERWARDS. THE 2 TIMES THREE (3) IMPLANTS COULD BE TENSIONED AND CUT AS PER THE DESIGN INTENT. AFTER CUTTING THE EXCESS MATERIAL OFF THE IMPLANTS THE PROTRUDING EXCESS MATERIAL HAD THE CORRECT LENGTH - AS PER THE DESIGN INTENT. HOWEVER IT WAS FOUND THAT THE INSTRUMENT RETURNED HAD NOT BEEN LUBRICATED AS PER THE INSTRUCTIONS PROVIDED BY THE MANUFACTURER. THERE WAS NO DESIGN RELATED ISSUES FOUND ON THE RETURNED INSTRUMENT. 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

    A CONCERN WAS REPORTED REGARDING TWO ZIP-FIX GUNS. THE SURGEON FELT THAT INTRA-OPERATIVELY THE GUNS WERE CUTTING THE ZIP TIES LONGER THAN BEFORE, THE SURGEON ADJUSTED THE LENGTH OF THE TIP TIE END. THIS WAS NOT REVISION SURGERY, NO SURGICAL DELAY REPORTED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS REPORTED TO BE CLINICALLY STABLE THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726081 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 8520341

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR