BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLUBE-III W/20' HOSE

    MDR report key: 3738067 · Received April 10, 2014

    Report

    Report Number
    1045834-2014-11774
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 20, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PK970530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE SURGEON STATED THAT THE PATIENT HAD A ¿VERY ROUGH POSTOPERATIVE COURSE BUT IT WAS NOT DUE TO THE INJURY FROM THE MOTOR DEVICE¿. NO SPECIFIC INTERVENTIONS WERE REQUIRED AS A RESULT OF THIS EVENT. IT WAS STATED THAT THE SURGEON BELIEVES THE DEVICE MALFUNCTIONED BECAUSE THE CLUTCH DID NOT ENGAGE. 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 ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. THE DEVICE WOULD NOT BE TESTED DUE TO DEBRIS IN THE SYSTEM. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IT WAS INDICATED THAT THE FOOT CONTROL DEVICE CONTROLS THE SPEED AND LUBRICATION OF THE DRILL AND DOES NOT CONTRIBUTE TO THE PERFORMANCE OF THE CLUTCH MECHANISM ON THE PERFORATOR. 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

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A CRANIOTOMY SURGERY, WHILE UTILIZING A FOOT CONTROL DEVICE, COMPACT SPEED REDUCER DEVICE, MOTOR DEVICE, AND PERFORATOR DEVICE TOGETHER, THE PERFORATOR DEVICE "DID NOT STOP" AND "KEPT GOING UNTIL IT WENT INTO THE DURA MATER". THE REPORTER STATED THAT THE DEVICE STOPPED BEFORE REACHING THE BRAIN TISSUE. THE REPORTER WAS UNABLE TO CLARIFY WHICH CRANIAL BONE WAS INVOLVED, WHETHER THE DURA MATER WAS DAMAGED OR TORN, OR IF THE DEVICE PASSED THROUGH THE DURA MATER INTO THE ARACHNOIDS OR FURTHER. THE REPORT INDICATED THAT A SERIOUS INJURY OCCURRED. THE REPORTER STATED THAT THE PATIENT HAD PREVIOUS NEUROLOGICAL DAMAGE AND COULD NOT CONFIRM WHETHER OR NOT ADDITIONAL DAMAGE HAD OCCURRED. THE REPORT INDICATED THAT THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. A TWENTY MINUTE DELAY WAS CAUSED BY THE NEED TO REMOVE AND ISOLATE ALL DEVICES INVOLVED WITH THE EVENT AND TO THEN RETRIEVE, OPEN, AND SET-UP A NEW SET OF SPARE DEVICES. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217171 AUTOLUBE-III W/20' HOSE MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PERFORATOR DEVICE| COMPACT SPEED REDUCER| MOTOR DEVICE