BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNERSCR F/UNT F/356.511

    MDR report key: 2763876 · Received September 25, 2012

    Report

    Report Number
    8030965-2012-00910
    Event Type
    Injury
    Date Received
    September 25, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4): INVESTIGATION COORDINATED BY SYNTHES GMBH. REPORT RECEIVED INDICATES THE CONNECTING SCREW HAS VISIBLE SIGNS OF SCRATCHES AND A PARTLY WORN OUT THREAD. THE REVIEW OF THE MATERIAL AND MANUFACTURING DOCUMENTS REVEALED THAT THE PRODUCT IS IN COMPLIANCE WITH ITS SPECIFICATIONS. THE EXACT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. THE INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE THE CONNECTION SCREW FOR UNT, END CAP, DID NOT FIT AND THE SCREW BROKE. THE SCREW WAS PLACED WITH PLIERS, AT THE TIME OF INTRODUCTION IN PT, THE SCREW BROKE INSIDE THE NAIL. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONNERSCR F/UNT F/356.511 CONNECSCR F/UNT HWC SYNTHES GMBH 3774419

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention END CAP| SCREW