BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 5362844 · Received January 13, 2016

    Report

    Report Number
    2520274-2016-10168
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). 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

    IT WAS REPORTED THAT TWO (2) 2.5MM DRILL BITS BROKE INTO SMALL FRAGMENTS DURING A PROCEDURE. THE SMALL FRAGMENTS OF THE DRILL BITS REMAINED IN THE PATIENT WHICH WAS CONFIRMED VIA X-RAY. THERE WAS NO HARM TO THE PATIENT. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE STATUS/OUTCOME OF THE PATIENT IS STABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23272 2.5MM DRILL BIT/QC/GOLD/110MM INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention