BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWDRIVERS: CMF

    MDR report key: 12970757 · Received December 9, 2021

    Report

    Report Number
    8030965-2021-10106
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 11, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER SHAFT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN OSTEOTOMY WITH MOJ SYSTEM, THE DRIVER SHAFT WAS NOT ABLE TO HOLD A SCREW. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN SCREWDRIVER SHAFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866289 UNK - SCREWDRIVERS: CMF SCREWDRIVER HXX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - SCREWS: CMF