BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEADED PIN IMPACTOR EXTRACTOR

    MDR report key: 3111513 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01666
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MISSING OVERMOLD MATERIAL INVOLVING A HEADED PIN IMPACTOR/EXTRACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS REPORT CONCLUDED THAT ¿NOTHING COULD BE LEARNED ABOUT THE CAUSE OF THE MISSING OVERMOLD FROM EXAMINATION OF THE SMALL AMOUNTS OF OVERMOLD MATERIAL LEFT IN THE HOLES OF THE ARM.¿ MEDICAL RECORDS EVALUATION NOT PERFORMED BECAUSE NO PATIENT INFORMATION, PATIENT INVOLVEMENT, OR ADVERSE CONSEQUENCES WERE REPORTED. DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE DEVICE HAS BEEN IN SERVICE FOR 7 YEARS AND IT IS BELIEVED THE GREEN SANTOPRENE OVERMOLD HANDLES OF TRIATHLON INSTRUMENTS DEGRADES OVER TIME, CAUSING THE REPORTED FAILURE MODE. BASED ON THE CONDITION OF THE RETURNED PRODUCT, IT CANNOT BE DETERMINED WHETHER OR NOT THE DEVICE HAD ANY MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS OBSERVED THAT MATERIAL OF THE REPORTED DEVICE HAS COME LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS OBSERVED THAT MATERIAL OF THE REPORTED DEVICE HAS COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211768 HEADED PIN IMPACTOR EXTRACTOR INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other