BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA CLAMP

    MDR report key: 3781414 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01575
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DEGRADED HANDLES INVOLVING A TRIATHLON PATELLAR CLAMP WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND 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.

    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 WHILE CHECKING INSTRUMENTS, I NOTICED THE RUBBER HANDLES ON THE PATELLA CLAMP, AND THE PATELLA CALIPER WERE STICKY AND THE RUBBER APPEARS TO BE UNSTABLE AND EASILY SCRAPED WITH A FINGER NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHECKING INSTRUMENTS I NOTICED THE RUBBER HANDLES ON THE PATELLA CLAMP, AND THE PATELLA CALIPER WERE STICKY AND THE RUBBER APPEARS TO BE UNSTABLE AND EASILY SCRAPED WITH A FINGER NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260151 PATELLA CLAMP INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH C3S18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other