BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX MINI-OPEN IMPLANT COUPLING

    MDR report key: 5408309 · Received February 3, 2016

    Report

    Report Number
    1719045-2016-10104
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Report Date
    January 19, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE STERILITY DOCUMENTATION WAS ALSO REVIEWED AND DETERMINED TO BE CONFORMING. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SUBJECT DEVICE (SYNFIX MINI-OPEN IMPLANT COUPLING, PART NUMBER 03.802.200, LOT NUMBER 9944751). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT THAT THE THREADED TIP BROKE DURING STERILE PROCESSING. THE IMPLANT COUPLING IS SPECIFICALLY UTILIZED TO MOUNT AN AIMING DEVICE TO THE SYNFIX IMPLANT. THE SYSTEM TECHNIQUE GUIDE SPECIFICALLY NOTES THAT THE ¿AIMING DEVICE SHOULD FIT SNUGLY AGAINST THE PLATE. DO NOT OVER TIGHTEN¿. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: TOP-LEVEL AND THREADED SHAFT. 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 LOT NUMBER (AS PREVIOUSLY REPORTED) AND NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE SUBJECT DEVICE WAS RECEIVED WITH THE DISTAL-MOST 12MM MISSING. THE COMPLAINT CONDITION WAS CONFIRMED. BASED ON THE COMPLAINT DESCRIPTION THE BROKEN TIP OCCURRED DURING STERILE PROCESSING, AS SUCH A ROOT CAUSE RELATED TO ROUGH HANDLING WAS DETERMINED. 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 IS REPORTED THAT DURING REVIEW OF FIELD EQUIPMENT ONE (1) SYNFIX MINI-OPEN IMPLANT COUPLING WAS BROKEN. IT IS REPORTED THE TIP OF THE COUPLING WAS BROKEN OFF IN A WIRE BASKET WHILE BEING WASHED. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65260 SYNFIX MINI-OPEN IMPLANT COUPLING MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 9944751

    Patients

    Seq Age Sex Outcome Treatment
    1