BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIT, DRILL

    MDR report key: 4252400 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14764
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DRILL BIT/UNKNOWN LOT. 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 INTERFERED WITH THE NAIL. THE SURGEON MANAGED TO MAKE THE DRILL TIP GO THROUGH BY ADJUSTING IT BY HAND. THE SURGEON COMMENTED THAT A DIRECTION MIGHT BE AWAY FROM THE TARGET BY SLIPPING OUT ON PERIOSTEUM DURING THE SURGERY BECAUSE THE PATIENT¿S BONE WAS CARVED. THE SURGERY WAS DELAY FOR TWO MINUTES DUE TO THIS EVENT. THIS REPORT IS FOR AN UNKNOWN DRILL BIT. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736223 BIT, DRILL HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1