BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 4089920 · Received September 15, 2014

    Report

    Report Number
    2520274-2014-13654
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). 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. 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 DURING SURGERY THE CONTRA ANGLE DRIVERS WOULD NOT ADAPT TO THE POWER TOOL THE HOSPITAL HAD PREPARED. THE SURGEON HAD TO WAIT FOR A DIFFERENT SCREWDRIVER TO UTILIZE WITH THE POWER TOOL, THIS DELAYED THE OPERATION FOR AN UNKNOWN AMOUNT OF TIME. THERE WAS NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569479 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1