BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM DRILL BIT/QC/145MM

    MDR report key: 11076752 · Received December 28, 2020

    Report

    Report Number
    8030965-2020-09974
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    November 29, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819018693
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS A J&J SALES REPRESENTATIVE. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 310.310, LOT: 2102218, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 01.SEP.2004, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 AN UNKNOWN DATE DRILL BIT WAS UNABLE TO CUT WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543943 3.2MM DRILL BIT/QC/145MM INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT HWE SYNTHES GMBH 2102218 07611819018693

    Patients

    Seq Age Sex Outcome Treatment
    1