BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 3041936 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10568
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 25, 2012
    Report Date
    March 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BASED ON THE DHR EVALUATION PERFORMED, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE DRILL BIT WAS RETURNED WITH THE 6MM DIAMETER TIP BROKEN OFF. PART SHOWS BURRS AND MATERIAL DISCOLORATION AT THE BREAK SITE. THERE IS SIGNIFICANT DAMAGE TO THE CUTTING EDGES ON THE TIP AND ALONG THE FLUTES AND MINOR SCRATCHES AND WEAR MARKS ARE PRESENT ON THE SHAFT. THE DAMAGE IS POTENTIALLY CONSISTENT WITH USAGE IN THE FIELD. THE REMAINING UNDAMAGED PERTINENT FEATURES RELATED TO THE COMPLAINT WERE INSPECTED AND FOUND CONFORMING. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE EVALUATION OF THE REMAINING PART OF THE DRILL BIT PERFORMED ON THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE. DUE TO THE LOW OCCURRENCE RATE AND LIFE OF THE PRODUCT THERE DOES NOT SEEM TO BE AN APPARENT DESIGN ISSUE. THEREFORE THE COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL FEMUR FRACTURE PROCEDURE, THE DRILL BIT TIP BROKE INTO PIECES WHEN THE SURGEON WAS DRILLING OVER THE 3.2MM GUIDE WIRE, AND INTO THE FEMORAL HEAD. THE BROKEN PIECES WERE RETRIEVED WITH A PITUITARY RONGEUR AND THEN DISCARDED. THE MAIN PORTION OF THE DRILL BIT WAS RETRIEVED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143363 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM HTO SYNTHES MONUMENT US92377

    Patients

    Seq Age Sex Outcome Treatment
    1