BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLING BIT

    MDR report key: 4436367 · Received January 21, 2015

    Report

    Report Number
    2520274-2015-10514
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Date of Event
    December 31, 2014
    Report Date
    December 31, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: GFG. 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 THE DRILL DID NOT CORRECTLY FUNCTION. IT STATED THAT IT ONLY ¿UNMELTED ¿TWICE WHEN CONNECTED TO POWER/BASE UNIT. DISMANTLED AND RE-ATTEMPTED MULTIPLE TIMES. THERE WAS NO PATIENT HARM. THE SURGERY WAS PROLONGED ABOUT 30MINS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE JERKED TICE WHEN CONNECTED TO THE POWER/BASE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50427 MILLING BIT MISC ORTHO SURGICAL INSTR LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1