BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE

    MDR report key: 6148815 · Received December 6, 2016

    Report

    Report Number
    3000270450-2016-10289
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. ADDITIONAL DEVICE PRODUCT CODE: FSM. (B)(6). DEVICE HISTORY RECORD (DHR) REVIEW FOR PART # 03.221.011 LOT # 9142563: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 16. JAN. 2015. 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 319.006, LOT NUMBER 6451382). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE TIPS / TUBES FROM THE INSTRUMENT PLIERS ARE DEFORMED. THE COMPLAINT IS CONFIRMED. THE DOCUMENT REVIEW FOR MATERIAL AND PRODUCTION SHOWED THE INSTRUMENT HAS BEEN PRODUCED IN JANUARY 16, 2015 AND PRINT SPECIFICATION. FURTHERMORE THESE INSTRUMENTS UNDERWENT A 100% FUNCTIONAL INSPECTION BEFORE LEAVING THE PLANT. THE MOST PROBABLE ROOT CAUSE IS AN EXCEEDING FORCE HAS LED TO THE DEFORMATION. 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 THE ENDS OF BOTH SLEEVES OF A CERCLAGE PASSER DO NOT FIT OR DO NOT CLOSE PROPERLY. THE ISSUE WAS DETECTED POSTOPERATIVELY BEFORE CLEANING PROCESS, THEREFORE NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798606 CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE MISC ORTHO SURGICAL INSTR LXH SYNTHES SELZACH 9142563

    Patients

    Seq Age Sex Outcome Treatment
    1