BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 13471616 · Received February 7, 2022

    Report

    Report Number
    8030965-2022-00725
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    November 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819499188
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OVERALL COMPLAINT WAS CONFIRMED FOR DRIVING CAP F/INSERTION HANDLE (PRODUCT CODE: 03.010.523 LOT #: 9890849). NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART #: 03.010.523. LOT #: 9890849 MANUFACTURING SITE: (B)(6). RELEASE TO WAREHOUSE DATE: 04 JUL 2016. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2021, THE FAULTY DRIVE CAP WAS USED WHICH LEAD TO UNSPECIFIED DAMAGE. SURGICAL DELAY OF FIFTEEN MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM REPORTED. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975396 DRIVING CAP/THREADED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9890849 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown