BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM X 10MM FLUTED TWIST DRILL BIT

    MDR report key: 3052934 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01280
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    December 24, 2012
    Report Date
    February 19, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE COMPLETION OF THE EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT WAS INCORRECT. THE CORRECT DATE OF EVENT WAS (B)(6) 2012. THE DATE RECEIVED BY MANUFACTURER WAS INCORRECT. THE CORRECT DATE RECEIVED BY MANUFACTURER WAS 02/19/2013. THE DATE RETURNED TO MANUFACTURER WAS INCORRECT. THE CORRECT DATE RETURNED TO MANUFACTURER WAS 04/26/2013. DEVICE EVALUATION: THE ACTUAL DEVICE HAS BEEN RETURNED. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. A VISUAL INSPECTION OF THIS DEVICE WAS PERFORMED UNDER 10X MAGNIFICATION. DURING INSPECTION, IT WAS OBSERVED THAT THE TIP OF THE DEVICE BROKE OFF. EVIDENCE SUGGESTED THAT THE CUTTER WAS EXPOSED TO EXCESSIVE LATERAL FORCE DURING USE. THE DEVICE IS DESIGNED FOR PLUNGE CUTTING HOLES ONLY. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY CONDITIONS DURING MANUFACTURING OPERATIONS THAT COULD BE RELATED TO THE REPORTED CONDITION. THE ATTACHMENT DEVICE PASSED ALL MANUFACTURING AND TEST REQUIREMENTS AT THE TIME OF MANUFACTURE. A TREND REVIEW INDICATED NO INCREASE IN COMPLAINTS OF THIS NATURE FOR THIS DEVICE. MONITORING WILL BE CONDUCTED FOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF COMPLAINT HISTORY OVER THE PREVIOUS 12 MONTHS DID NOT INDICATE ANY INCREASING TREND IN COMPLAINTS OF THIS NATURE FOR THIS PRODUCT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT DURING A LEPTOMENINGEAL CYST REMOVAL THE TIP OF THE DEVICE "BROKE OFF". THE DRILL BIT AND THE BROKEN PIECES WERE RETRIEVED. IT WAS UNKNOWN WHETHER OR NOT ANY FURTHER MEDICAL INTERVENTION WAS REQUIRED AFTER RETRIEVING THE PIECES. THE DEVICE WAS STERILIZED BY THE USER FACILITY TO BE RETURNED FOR INVESTIGATION, NOT FOR REUSE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137150 1.5MM X 10MM FLUTED TWIST DRILL BIT HBC THE ANSPACH EFFORT, INC. F133063522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention