BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 5721064 · Received June 13, 2016

    Report

    Report Number
    3003875359-2016-10352
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.501.080 WITH LOT NUMBER 9812895 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS FEBRUARY 11, 2016. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. NO 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. 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

    A SERVICE AND REPAIR EVALUATION WERE PERFORMED: THE CUSTOMER REPORTED THE ITEM WOULD NOT PULL OR RATCHET THE ZIP FIX WIRE. THE REPAIR TECHNICIAN REPORTED THE CUTTING ARM WAS STICKING AND BINDING, AND ONE OF THE SCREWS WAS LOOSE. BINDING IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. NO PARTS WERE REPLACED. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 10-JUN-2016 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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

    ON (B)(6) 2016, DURING AN UNSPECIFIED SURGERY, THE APPLICATION INSTRUMENT FOR THE STERNAL ZIPFIX WOULD NOT PULL OR RATCHET THE ZIPFIX WIRE. IT WAS REPORTED THAT ANOTHER APPLICATOR DEVICE WAS USED WITHOUT DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: ZIPFIX (PART 08.501.001.01S, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374237 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ SYNTHES HAGENDORF 9812895

    Patients

    Seq Age Sex Outcome Treatment
    1