BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 4372334 · Received December 30, 2014

    Report

    Report Number
    0002249697-2014-05037
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PIN HOLE IN AN INNER POWDER POUCH INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: BASED ON THE VISUAL INSPECTION, THERE IS A PIN HOLE PRESENT NEAR THE EDGE OF THE TOP OF THE INNER POUCH. THERE ARE IMPRESSIONS ON THE POUCH ABOVE THE PIN HOLE. THESE IMPRESSIONS AND THE PIN HOLE APPEAR TO HAVE BEEN CAUSED BY A FORCEPS BEING USED TO GRIP THE INNER POUCH TO REMOVE IT IN A STERILE MANNER FROM THE OUTER POUCH IN THE OR. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS THE REPORTED COMPONENT WAS NOT IMPLANTED. DEVICE HISTORY REVIEW: BMR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE WERE NO SIMILAR EVENTS REPORTED FOR THE LOT. CONCLUSIONS: BASED ON THE VISUAL INSPECTION, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE PINHOLE TO BE AS A RESULT OF FORCEPS OR SIMILAR INSTRUMENT BEING USED TO REMOVE THE INNER POUCH FROM THE OUTER POUCH IN THE OPERATING ROOM. THE PRODUCT WAS NOT SHIPPED IN THIS CONDITION AS INDICATED BY THE VISUAL EVIDENCE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PIN HOLE WAS CONFIRMED ON THE INNER PACKAGE BEFORE USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PIN HOLE WAS CONFIRMED ON THE INNER PACKAGE BEFORE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859217 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH JFV019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other