BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM CANNULATED DRILL BIT/QC 150MM

    MDR report key: 10969285 · Received December 8, 2020

    Report

    Report Number
    8030965-2020-09508
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 11, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819086074
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: HSZ, GFA, GFF. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE 2.0MM CANNULATED DRILL BIT BROKE DURING USE. THERE WAS NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.0MM CANNULATED DRILL BIT/QC 150MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432992 2.0MM CANNULATED DRILL BIT/QC 150MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 07611819086074

    Patients

    Seq Age Sex Outcome Treatment
    1