BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADED PIN IMPACTOR EXTRACTOR

    MDR report key: 3910377 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02501
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DEGRADED HANDLES INVOLVING A TRIATHLON HEADED PIN IMPACTOR EXTRACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL ANALYSIS CONFIRMED THE REPORTED EVENT. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE IT IS BELIEVED PATIENT FACTORS DID NOT CONTRIBUTE TO THE REPORTED EVENT. - DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO STOCK MET SPECIFICATION. - COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS ASSOCIATE WITH THE REPORTED LOT. CONCLUSION: CAPA WAS INITIATED BECAUSE A SERIES OF COMPLAINTS WERE RECEIVED FOR TRIATHLON INSTRUMENTATION WHERE GREEN SANTOPRENE OVER-MOLD HANDLES HAVE BEEN REPORTED TO BE DEGRADING, BECOMING STICKY AND UNSTABLE. THIS EVENT WAS DETERMINED TO BE UNDER THE SCOPE OF CAPA. CHEMICAL AND CYTOTOXICITY TESTS SHOWED THE DEGRADED SANTOPRENE IS NON-TOXIC. THE ABILITY TO CLEAN AND STERILIZE THE DEGRADED INSTRUMENTS HAS NOT BEEN COMPROMISED.

    Description of Event or Problem · 1

    I WAS COVERING A CASE FOR RJ AND SPD PERSONAL SHOWED ME A PART WITH GREEN COATING COMING OFF AFTER WASH CYCLE OF REPROCESSING.

    Description of Event or Problem · 1

    I WAS COVERING A CASE FOR (B)(4) SHOWED ME A PART WITH GREEN COATING COMING OFF AFTER WASH CYCLE OF REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388570 HEADED PIN IMPACTOR EXTRACTOR INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other