BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK OR SCREW HOLDER

    MDR report key: 6119028 · Received November 21, 2016

    Report

    Report Number
    2530088-2016-10320
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    November 14, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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. ADDITIONAL DEVICE PRODUCT CODE IS GDG. 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. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: MAY 16, 1996. 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. 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 PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED HOLDER WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL PRONGS OF THE OUTER SLEEVE WERE FOUND TO BE BROKEN AND MISSING; THE THREADED TIP OF THE INNER SHAFT WAS FOUND TO BE INTACT. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF OFF-AXIS LOADING LEADING TO DEVICE FAILURE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE HOOK OR SCREW HOLDER (338.61) IS NOTED IN BOTH THE USS AND THE USS VAS SYSTEM TECHNIQUE GUIDES. IN EACH SYSTEM THE DEVICE IS UTILIZED FOR PLACEMENT OF SCREWS AND HOOKS IN THE USS SYSTEM. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL AND OUTER SLEEVE. 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 NON-CONFORMANCE REPORTS, MATERIAL REVIEW REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 (B)(4) REPORTS THE FOLLOWING EVENT: IT WAS REPORTED THAT A HOOK OR SCREW HOLDER DEVICE WAS FOUND IN CENTRAL PROCESSING DEPARTMENT WITH THE TIP SHEARED OFF. IT IS UNKNOWN WHEN THE DEVICE BREAKAGE OCCURRED; HOWEVER, THERE WAS NO REPORT OF PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767531 HOOK OR SCREW HOLDER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BRANDYWINE A4FD049

    Patients

    Seq Age Sex Outcome Treatment
    1