BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

    MDR report key: 3890940 · Received June 24, 2014

    Report

    Report Number
    2520274-2014-12129
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: THIS REPORT IS FOR AN UNKNOWN ELECTRONIC PEN CONSOLE/UNKNOWN LOT. COMMON DEVICE NAME: ADDITIONAL PRODUCT CODES: DZI, ERL, HBE. IMPLANT/EXPLANT DATE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE AN ELECTRONIC PEN CONSOLE WOULD ONLY WORK IN REVERSE AND A BURR ATTACHMENT WOULD NOT SPIN AT ALL. THE SETS WERE BOOKED FOR A HIP REVISION CASE TO BURR OUT CEMENT TO PREVENT A FEMUR FRACTURE DURING CEMENT REMOVAL. DURING THE CASE, THE PEN DRIVER WOULD ONLY WORK IN REVERSE AND NOT FORWARD. THE CONSOLE WOULD LIGHT UP BUT THE PEN DRIVE WOULD NOT MAKE ANY NOISE. IN BOTH REVERSE AND FORWARD THE BURR WOULD NOT SPIN IN THE BURR ATTACHMENT. WHILE TRYING TO REMOVE CEMENT WITH RASPS, THE FEMUR CRACKED SO ANOTHER TREATMENT OPTION WAS USED TO FINISH THE PROCEDURE. THE PROCEDURE WAS DELAYED BY FORTY-FIVE MINUTES. THIS REPORT IS FOR AN UNKNOWN ELECTRONIC PEN CONSOLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367459 INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention