BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" PEG DRILL

    MDR report key: 3781180 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01682
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION. AN EVENT REGARDING FRACTURE INVOLVING A TRIATHLON 1/8¿ PEG DRILL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS INDICATED THE DEVICE FRACTURED FROM A MIXED-MODE OVERLOAD THROUGH A BENDING LOAD. -MEDICAL RECORDS RECEIVED AND EVALUATION: RECORDS WERE NOT PROVIDED FOR REVIEW. THERE IS NO INDICATION THE EVENT IS PATIENT RELATED. -DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: THE INVESTIGATION CONCLUDED THE DEVICE FRACTURED IN A MIXED-MODE OVERLOAD THROUGH A BENDING TYPE LOADING. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    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 THE 1/8 STOP DRILL BROKE DURING TKA. THE SURGEON NOTICED IT WHEN THE DRILL BROKE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 1/8 STOP DRILL BROKE DURING TKA. THE SURGEON NOTICED IT WHEN THE DRILL BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259675 1/8" PEG DRILL INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH SC6V07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other