BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE

    MDR report key: 6044769 · Received October 20, 2016

    Report

    Report Number
    1719045-2016-10766
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 27, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE INSERTION HANDLE (PART NUMBER 03.010.486, LOT NUMBER 9102635) AND CONNECTING SCREW (PART NUMBER 03.010.146, LOT NUMBER U212863). THE SUBJECT DEVICES WERE RETURNED WITH THE COMPLAINT CONDITION STATING THE ALIGNMENT TAB OF THE INSERTION HANDLE WAS DEFORMED. THE DISTAL THREADS OF THE CONNECTING SCREW WERE EXAMINED UNDER MAGNIFICATION AND FOUND TO BE IN GOOD CONDITION. THE HANDLE AND CONNECTING SCREW WERE TESTED WITH A KNOWN GOOD TIBIAL NAIL AND THEY WERE ABLE TO ASSEMBLE TO AND RETAIN THE NAIL AS INTENDED. THE COMPLAINT WAS CONFIRMED FOR THE INSERTION HANDLE. AS NO DEFECTS OR DEFICIENCIES WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION WERE IDENTIFIED FOR THE CONNECTING SCREW AND THE COMPLAINT CONDITION WAS UNABLE TO BE REPRODUCED. THE COMPLAINT RELATED TO THE CONNECTING SCREW IS UNCONFIRMED. NO FURTHER ACTIONS INCLUDING DRAWING REVIEW, COMPLAINT HISTORY REVIEW AND RISK ASSESSMENT REVIEW WILL BE COMPLETED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED CONNECTING SCREW¿S LOT NUMBER AND NO COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED INSERTION HANDLE WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH ROUGH HANDLING. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.146 LOT # U212863. RELEASE TO WAREHOUSE. DATE: DEC 08, 2014, SUPPLIER: (B)(4). NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE 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

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT AN INTRAMEDULLARY FEMORAL NAIL PROCEDURE. DURING THE PROCEDURE, THE INSERTION HANDLE BECAME LODGED ONTO THE NAIL AND REFUSED TO BACK OUT WITHOUT GREAT EFFORT. THE INSERTION HANDLE BENT AND THE LOCKING TAB AT THE END OF THE HANDLE IS DEFORMED. THE REPORTER STATES THAT THE THREADS ON THE CONNECTING SCREW ARE DEFORMED AND THAT IS THE REASON OF NOT BEING ABLE TO GET IT DISENGAGED FROM THE NAIL. THERE WAS A 2-3 MINUTE DELAY IN SURGERY. NO PATIENT HARM REPORTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696215 CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE GUIDE FZX SYNTHES MONUMENT U212863

    Patients

    Seq Age Sex Outcome Treatment
    1 NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1)