BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" PEG DRILL

    MDR report key: 3885006 · Received June 19, 2014

    Report

    Report Number
    0002249697-2014-02374
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURED DRILL BIT LEFT IN THE PATIENT INVOLVING A 1/8" PEG DRILL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A MATERIAL ANALYSIS CONCLUDED NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. THE PEG DRILL DEVICE FRACTURED IN FAST FRACTURE OVERLOAD AND DUCTILE SHEAR OVERLOAD RESULTING FROM THE APPLICATION OF A RIGHT-HANDED ROTATIONAL FORCE. MEDICAL RECORDS RECEIVED AND EVALUATION: THE FRACTURED DRILL BIT WAS LEFT IN THE PATIENT. REVIEW OF THE PROVIDED INFORMATION BY A CONSULTING CLINICIAN CONCLUDED - THERE IS NO EVIDENCE THE FRACTURED DRILL BIT WAS THE RESULT OF FACTORS OF FAULTY MANUFACTURING OR MATERIALS. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE PEG DRILL DEVICE FRACTURED IN FAST FRACTURE OVERLOAD AND DUCTILE SHEAR OVERLOAD RESULTING FROM THE APPLICATION OF A RIGHT-HANDED ROTATIONAL FORCE. NO MATERIALS OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE. A MEDICAL REVIEW CONCLUDED THERE IS NO EVIDENCE THE FRACTURED DRILL BIT WAS THE RESULT OF FACTORS OF FAULTY MANUFACTURING OR MATERIALS.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE TRIATHLON 1/8TH STEP DRILL IN THE RESECTED TIBIA TO PREDRILL BEFORE INSERTING THE HEADED TIBIAL BASEPLATE PINS. WHEN HE WAS INSERTING THE HEADED PIN IT DID NOT ADVANCE, IT WAS THEN NOTICED THAT THE STEP DRILL HAD BROKEN. THE SURGEON TRIED TO RETRIEVE THE BROKEN DRILL END WITH AN ARTERY FORCEP AND THEN MADE THE DECISION TO LEAVE THE DRILL END INSITU BECAUSE HE BELIEVED HE WOULD MAKE IT WORSE IF HE CONTINUED TRYING TO RETRIEVE IT. THE CASE CONTINUED AS PLANNED. A POST OPERATIVE XRAY WAS TAKEN IN RECOVERY AND THE PATIENT WAS INFORMED OF THE RETAINED DRILL BIT END BY THE REGISTRAR.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE TRIATHLON 1/8TH STEP DRILL IN THE RESECTED TIBIA TO PREDRILL BEFORE INSERTING THE HEADED TIBIAL BASEPLATE PINS. WHEN HE WAS INSERTING THE HEADED PIN IT DID NOT ADVANCE, IT WAS THEN NOTICED THAT THE STEP DRILL HAD BROKEN. THE SURGEON TRIED TO RETRIEVE THE BROKEN DRILL END WITH AN ARTERY FORCEP AND THEN MADE THE DECISION TO LEAVE THE DRILL END INSITU BECAUSE HE BELIEVED HE WOULD MAKE IT WORSE IF HE CONTINUED TRYING TO RETRIEVE IT. THE CASE CONTINUED AS PLANNED. A POST OPERATIVE XRAY WAS TAKEN IN RECOVERY AND THE PATIENT WAS INFORMED OF THE RETAINED DRILL BIT END BY THE REGISTRAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362024 1/8" PEG DRILL INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH SC5N10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other