BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM/8.0MM PROTECTION SLEEVE

    MDR report key: 2994005 · Received February 27, 2013

    Report

    Report Number
    2530088-2013-10194
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IT IS REPORTED THAT THE PT IS (B)(6). THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED MINOR SCRATCHES AND DINGS ON THE PART THAT IS CONSISTENT WITH FIELD USE. THE PRODUCT INVESTIGATION REVEALED THAT THE COMPLAINT IS DEEMED INVALID. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP FRACTURE TFN FIXATION SURGERY, THE SURGEON INSERTED THE TFN AND WHEN HE WENT TO INSERT THE HELICAL BLADE, THE BLADE KEPT HITTING THE EDGE OF THE NAIL. THE SURGEON TRIED REALIGNING SEVERAL TIMES AND NOTHING HELPED. THE DISTAL LOCKING HOLE WAS ALSO OUT OF ALIGNMENT. THE SURGERY WAS DELAYED BY THIRTY MINUTES DUE TO MALFUNCTIONING DEVICES. THIS IS EVENT 10 OF 14 FOR THIS REPORT. THIS COMPLAINT IS ON THE PROTECTION SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84149 11.0MM/8.0MM PROTECTION SLEEVE FZX SYNTHES (USA) BRANDYWINE 4575028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention