BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DRILL BIT/QC/85MM

    MDR report key: 4533750 · Received February 22, 2015

    Report

    Report Number
    2520274-2015-11086
    Event Type
    Malfunction
    Date Received
    February 22, 2015
    Date of Event
    February 8, 2015
    Report Date
    February 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE INSTRUMENT AND IS AN IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DRILL BIT BROKE DURING SURGERY. THERE WAS NO PATIENT HARM. THE TIP OF THE DRILL BIT WAS REMOVED. THERE WERE NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124745 1.5MM DRILL BIT/QC/85MM INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1