BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE

    MDR report key: 7201669 · Received January 17, 2018

    Report

    Report Number
    8030965-2018-50442
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 21, 2017
    Report Date
    December 21, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819880108
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, CUSTOMER IS RETAINING THE PRODUCT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 03.221.011, SYNTHES LOT NUMBER: 8264513: RELEASE TO WAREHOUSE DATE: 24.APR.2013, MANUFACTURING SITE: (B)(4): NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MISALIGNMENT OCCURRED WHEN COMBINING TWO PASSERS. NO PATIENT WAS INVOLVED. CONCOMITANT DEVICES REPORTED: CERCLAGE TUNNELING DEVICE (PART # 03.221.002, LOT # 8080042, QUANTITY 1), CERCLAGE TUNNELING DEVICE LARGE (PART # 03.221.004, LOT # 8755104, QUANTITY 1), TROCAR FOR CERCLAGE PASSER (PART # 03.221.003, LOT # 8737916, QUANTITY 1), TROCAR FOR CERCLAGE PASSER (PART # 03.221.003, LOT # 8771249, QUANTITY 1). THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44744 CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 8264513 07611819880108

    Patients

    Seq Age Sex Outcome Treatment
    1