BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125°

    MDR report key: 3002935 · Received March 13, 2013

    Report

    Report Number
    0009610622-2013-00113
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REVIEW OF THE DHR REVEALED NO DEVIATION. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DEVIATION DURING THE PACKAGING PROCESS. THE HAIR WAS FOUND AT THE RIM OF THE BLISTER POUCH ON THE GLUE AREA. THE TYVEK LID HAD BEEN PEELED OFF ALREADY BY THE USER. THE TYVEK LID SHOWS A CORRESPONDING IMPRINT THAT WAS CAUSED BY THE CAPTURED HAIR. THUS IT COULD BE CONCLUDED THAT THE HAIR GOT CAPTURED DURING THE SEALING PROCESS AT THE SUPPLIER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SCRUB NURSE WAS OPENING THE PACKAGE, A LONG RED HAIR WAS STUCK TO THE GLUE INSIDE AND ALSO STUCK OUT OF THE INNER BLISTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SCRUB NURSE WAS OPENING THE PACKAGE, A LONG RED HAIR WAS STUCK TO THE GLUE INSIDE AND ALSO STUCK OUT OF THE INNER BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105716 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K700548

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other