BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AO/ASIF-QC F/COMPACT AIR DRIVE+POWER DRI

    MDR report key: 6221347 · Received January 4, 2017

    Report

    Report Number
    8030965-2017-10017
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTER NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WAS AN ADDITIONAL CUTTER DEVICE INVOLVED IN THIS EVENT. THEREFORE, THIS IS REPORT 2 OF 5 OF THE SAME EVENT. (B)(4). THE LOT NUMBER WAS REPORTED AS UNKNOWN IN THE INITIAL MEDWATCH, THE LOT NUMBER IS MA1190. (B)(6). 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 DATE RETURNED TO MANUFACTURER WAS DOCUMENTED AS JAN 27, 2017 ON THE INITIAL REPORT. IT HAS BEEN UPDATED AS FEB 1, 2017. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THERE WAS NO FAILURE IDENTIFIED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 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.

    Description of Event or Problem · 1

    THIS IS EVENT 2 OF 4 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A DIAPHYSEAL SPIRAL SURGICAL PROCEDURE FOR A HUMERAL DIAPHYSIS FRACTURE, IT WAS OBSERVED THAT WHILE USING THE RADIOLUCENT DRIVE DEVICE THE DRILL BIT DEVICES STARTED TO WOBBLE. ACCORDING TO THE REPORTER, THE DRILL BIT DEVICES THEN STOPPED MOVING WHILE IN USE WITH THE DEVICE. THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO DRILL WHILE HOLDING THE BASE TIGHT AS THE SURGEON BELIEVED THERE WAS A CONNECTION ISSUE WITH THE HANDPIECE DEVICE. HOWEVER, THE SURGEON NOTED THAT THE JUNCTION OF THE DRILL BIT DEVICE AND QUICK COUPLING DEVICE DID NOT WORK PROPERLY. THE REPORTER STATED THAT THE SURGEON THEN ATTEMPTED TO FIX THE DRIVE TIP WITH TAPE SO THAT THE DRILL BIT DEVICE WOULD NOT FALL WITHOUT SUCCESS. THE REPORTER STATED THAT EVENTUALLY THE DRILL BUT DEVICE TIP WAS HIT WITH A HAMMER. THEREFORE, THE SURGEON OPENED THE OTHER SIDE WITH HIS HAND AND INSERTED SCREW DEVICES TO CONTINUE THE SURGICAL PROCEDURE. THE REPORTER FURTHER INDICATED THAT A COMPACT AIR DRIVE DEVICE WAS IN USE DURING THE PROCEDURE. ACCORDING TO THE REPORTER, THE CUTTER DEVICE DID NOT BREAK DURING THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WAS A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE WHICH CAUSED THE PATIENT TO LOSE BLOOD. THE AMOUNT OF BLOOD LOSS WAS NOT AVAILABLE FROM THE REPORTER. THE REPORTER WAS NOT ABLE TO SPECIFY IF/WHAT MEDICAL INTERVENTION WAS PERFORMED OR IF THERE WAS PROLONGED HOSPITALIZATION AS A RESULT OF THE EVENT. 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
    6674 AO/ASIF-QC F/COMPACT AIR DRIVE+POWER DRI INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS MA1190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention COMPACT AIR DRIVE| CUTTER DEVICE| RADIOLUCENT DRIVE