BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4MM DIAMOND BALL, 15CM

    MDR report key: 3874382 · Received June 16, 2014

    Report

    Report Number
    1045834-2014-12125
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK042783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: THERE WAS NO CONTACT PHONE NUMBER OR COMPLETE ADDRESS PROVIDED. THE DATE OF MANUFACTURE WAS UNKNOWN. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURNED TO THE MANUFACTURER WAS INCORRECTLY DOCUMENTED AS (B)(6) 2014 INSTEAD OF (B)(6) 2014. THE CORRECT DEVICE RETURNED DATE HAS BEEN CORRECTED TO (B)(6) 2014. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL ASSESSMENT WAS PERFORMED WHICH FOUND WITNESS MARKS ON THE CUTTER SHAFT FROM WORN BEARINGS. THE SHAFT WAS SCORED WHERE THE FRACTURE OCCURRED AND THERE WAS EVIDENCE OF LOCALIZED HEATING OF THE SHAFT. IT WAS NOTED THAT THE ATTACHMENT DEVICE SLEEVES WERE WORN AND REQUIRED REPLACEMENT FROM THE WORN BEARINGS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING A HYPOPHYSIS SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHEN THE CUTTING BURR DEVICE WAS INSERTED THROUGH THE NOSTRIL, IT BROKE SHORTLY AFTER THE SURGEON STARTED CUTTING THE BONE. ACCORDING TO THE REPORT, THERE WAS A 30 MINUTE DELAY TO THE SURGICAL PROCEDURE TO REMOVE THE BROKEN TIP OF THE DEVICE. IT WAS UNKNOWN TO THE REPORTER IF A SPARE DEVICE WAS AVAILABLE FOR USE OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. HOWEVER, THE TYPE OF MEDICAL INTERVENTION WAS UNKNOWN TO THE REPORTER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352102 4MM DIAMOND BALL, 15CM DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR HBE DEPUY SYNTHES POWER TOOLS F233066325

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention