BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 3202490 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04033
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PERFORMED FUNCTIONAL TEST WITH THE RETURNED DEVICE DID NOT SHOW ANY FUNCTIONAL ISSUES. THE DEVICE COULD BE NORMALLY CLOSED AND LOCKED. BASED ON THE FINDINGS, THE DEVICE FAILURE COULD NOT BE REPLICATED. NO DEFORMATIONS WERE FOUND WHICH COULD EXPLAIN THE FAILURE OF THE DEVICE DURING ITS APPLICATION. THE ROOT CAUSE OF THE PRODUCT OF THE DEVICE FAILURE CANNOT BE DETERMINED. THE COMPLAINT IS INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.DATE OF MANUFACTURE OBTAINED FROM REVIEW OF MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ZIPFIX DEVICE WOULD NOT LOCK AND ZIP TOGETHER DURING A PROCEDURE ON (B)(6) 2013. SURGEON USED ANOTHER ONE OUT OF A PACKET WHICH WORKED FINE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302171 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK JDQ SYNTHES GMBH 8327297

    Patients

    Seq Age Sex Outcome Treatment
    1