BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3853855 · Received June 6, 2014

    Report

    Report Number
    1045834-2014-12171
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 9, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT HAD THE INCORRECT DATE. THE DATE WAS LISTED AS (B)(4) 2014 AND SHOULD HAVE BEEN (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. VISUAL AND FUNCTIONAL ASSESSMENTS WERE PERFORMED WHICH FOUND THAT THERE WERE LOOSE/WORN OUT BEARINGS WHICH WERE NOT ALLOWING INSERTION OF THE CUTTER. IT WAS DETERMINED THAT THIS WOULD HAVE CAUSED VIBRATION AND HEAT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE NORMAL WEAR OF THE BEARINGS OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS UNKNOWN. THEREFORE, DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    REPORT 1 OF 2 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING COCHLEAR STYLE SURGERIES, IT WAS OBSERVED THAT THE MOTOR DEVICE, WHILE IN USE WITH AN ATTACHMENT DEVICE, WAS VIBRATING WITH A BIT OF HEATING. THE REPORTER FURTHER CLARIFIED THAT AS A RESULT, IT WAS CAUSING THE BURR TO DRILL IN A WIDER RADIUS THAN EXPECTED. THE REPORTER COULD NOT CLARIFY THE EXACT AMOUNT OF OCCURRENCES. THE REPORTER STATED THAT IT WAS MOSTLY NOTICED WHILE USING 1 TO 1.5 MM BURRS. THERE WERE SPARE DEVICES AVAILABLE FOR USE; HOWEVER, IT WAS NOT REPORTED IF THERE WERE DELAYS TO THE PLANNED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES. IT WAS NOT STATED WHAT OR IF MEDICAL INTERVENTION WAS REQUIRED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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
    332570 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CUTTER DEVICE| MOTOR DEVICE