BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER

    MDR report key: 4230308 · Received November 6, 2014

    Report

    Report Number
    1719045-2014-10570
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS RECEIVED WITH NO APPARENT SIGNS OF WEAR OR DAMAGE. FUNCTION TESTS WERE PERFORMED AND THE LEVER LOCK WAS CONFIRMED TO BE EXTREMELY STIFF AND UNABLE TO BE LOCKED. AFTER ADDITIONAL PERFORMANCE TESTING THE ITEM THEN FUNCTIONED NORMALLY AND WAS ABLE TO BE LOCKED, HOWEVER, THERE WAS NO DEMO CABLE TO PASS THROUGH AND TEST THE DEVICE PROPERLY. ACCORDING TO SUPPLIER DOCUMENTATION, ¿FUNCTIONAL INSPECTION FOUND THAT THE CAM LEVER WAS DIFFICULT TO MOVE INTO THE LOCKING POSITION. CAM SURFACE IS VERY ROUGH. INSTRUMENT MILK WAS APPLIED WHICH LOOSENED THE CAM LEVER FOR TESTING. PER THE DMR, A TENSIONER IS TESTED BY TENSIONING THE CABLE TO (B)(4) AND IS ACCEPTABLE IF THE DEVICE HOLDS THE CABLE. ONCE THIS INSTRUMENT WAS MILKED IT PASSED THE FUNCTIONAL TEST. THE DHR REVIEW CONFIRMED THIS PRODUCT MET SPECIFICATION PRIOR TO SHIPPING.¿ BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONFIRMED BUT IS NOT CONSIDERED MANUFACTURING-RELATED. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND DURING THE MANUFACTURE OF THE PRODUCT NO COMPLAINT RELATED ISSUES WERE FOUND. NO MRRS OR NCRS WERE GENERATED DURING PRODUCTION. 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 AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT A PERIPROSTHETIC FRACTURE OCCURED. THAT DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE WITH A PLATE AND TWO CABLES, THE LOCK LEVER ON ONE HANDED CABLE TENSIONER WAS EXTREMELY STIFF AND NOT LOCKING. TRIED STANDARD TENSIONER INSTEAD, BUT CABLE WAS ALREADY BENT DUE TO EXCESSIVE FORCE APPLIED SO WOULD NOT FEED THROUGH. HAD TO REMOVE CABLE AND START AGAIN. ONE HANDED TENSIONER LOCK LEVER ABLE TO LOCK ONCE REASSEMBLED, BUT ONLY WITH EXTREME FORCE. PATIENT OUTCOME TO BE DETERMINED. THERE WAS A 10 MINUTES DELAY IN SURGERY. NO PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713703 Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P125868

    Patients

    Seq Age Sex Outcome Treatment
    1