BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEC L141 F/INSERTION HANDLE

    MDR report key: 13569078 · Received February 21, 2022

    Report

    Report Number
    8030965-2022-01025
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07611819760844
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. A PHOTO INVESTIGATION WAS PERFORMED BASED ON THE IMAGES ATTACHED TO THE EMAIL ATTACHED IN THE NOTES & ATTACHMENTS SECTION OF PC TITLED "SOURCE FILE - NOVEDAD PIEZA COLECTIVO 286184". THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION IS NOT CONFIRMED. THERE IS NO VISIBLE DAMAGE TO THE THREADS OF THE DRIVING CAP. AS THE PHYSICAL DEVICE WAS NOT RECEIVED, A FUNCTIONAL TEST COULD NOT BE PERFORMED AND THEREFORE IT CANNOT BE CONFIRMED THAT DEVICE HAS DYSFUNCTIONAL THREADS. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGE) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES.,BACKGROUND: THE PIECE ARRIVED DAMAGED AND CANNOT BE USED. THE THREAD IS IN BAD CONDITION AND DID NOT THREAD WELL, SO IT COULD NOT BE USED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. VISUAL INSPECTION: THE DEVICE (CONNEC L141 F/INSERTION HANDLE, PRODUCT CODE: 03.010.047 LOT #: 9873266) WAS RETURNED AND RECEIVED AT CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE THREADS IN THE DEVICE WERE DAMAGED. NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TESTING: DUE TO THE DAMAGED THREADS, THE DRIVING CAP BODY CANNOT BE TOTALLY THREADED IN THE HANDLE ADAPTOR. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE RETURNED DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE UNINTENDED EXTERNAL FORCES MIGHT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 - PRODUCT CODE: 03.010.047 LOT NUMBER: 9873266 MANUFACTURING SITE: HAGENDORF RELEASE TO WAREHOUSE DATE: 27 MAY 2016 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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, THE THREAD OF THE INSERTION HANDLE ARRIVED DAMAGED AND DID NOT THREAD WELL. THIS REPORT IS FOR ONE (1) CONNEC L141 F/INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225479 CONNEC L141 F/INSERTION HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 9873266 07611819760844

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown