BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2

    MDR report key: 4719429 · Received April 22, 2015

    Report

    Report Number
    0002249697-2015-01332
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 30, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K132624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A HAIR IN THE INNER STERILE PACK INVOLVING A SINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2 WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION CONFIRMED A HAIR WITHIN THE INNER STERILE PACK. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES NOR MEDICAL INTERVENTION. DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES FOR THE LOT REFERENCED. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE DEVICE WAS NOT MADE TO SPECIFICATION AS A FOREIGN HAIR WAS PACKAGED IN THE INNER STERILE BLISTER PACK WITH THE DEVICE UNINTENDEDLY. NC WAS RAISED REGARDING THE COMPROMISED PACKAGING.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AS THE SINGLE USE TRIAL WAS BEING OPENED I NOTICED A HAIR INSIDE THE STERILE PACKAGING.

    Description of Event or Problem · 1

    AS THE SINGLE USE TRIAL WAS BEING OPENED I NOTICED A HAIR INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267351 SINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2 INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH 30061401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other