BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREW

    MDR report key: 3810485 · Received May 14, 2014

    Report

    Report Number
    2520274-2014-00999
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    December 10, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PRODUCT DEVELOPMENT EVENT EVALUATION: THE RETURNED EXTRACTION SCREW, LOT #, WAS MANUFACTURED FEBRUARY, 2012. IT WAS RECEIVED SHOWING WEAR MARKS AND SCRATCHES AND THE THREADED PORTION WAS STUCK IN THE CENTER ON THE PROXIMAL SIDE OF AN UNKNOWN SCREW HEAD. THE BALANCE OF THE EXTRACTION SCREW WAS IN GOOD CONDITION AND ALL ETCHINGS WERE LEGIBLE. A REVIEW OF THE CURRENT EDITION DRAWING, WAS PERFORMED. THE PART WAS MANUFACTURED AFTER THE CURRENT RELEASE DRAWING AND THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. THE UNKNOWN SCREW WAS RECEIVED BROKEN JUST BELOW THE HEAD AND THE LOWER THREADED PORTION WAS NOT RECEIVED. WITH THE GIVEN INFORMATION THE SCREW CANNOT BE IDENTIFIED. SIGNIFICANT EFFORT WAS PLACED IN ATTEMPT TO IDENTIFY THE SCREW. THE TYPE OF OPERATION (A 5TH METATARSAL REPAIR FOR A JONES FRACTURE), THE SCREW HEAD DIMENSIONS, THE SCREW CORE DIMENSION, THE SCREW FEATURES, THE EXTRACTION TOOL USED, AND THE ABSENCE OF ETCHINGS WERE ALL CONSIDERED BUT THE SCREW FAMILY STILL COULD NOT BE IDENTIFIED. THE RECOMMENDATIONS PER THE TECHNIQUE GUIDE ARE THAT THE EXTRACTION SCREW IS USED ONCE AND THAT THE EXTRACTION SCREW IS NOT TO BE INSERTED UNDER POWER. THIS STUCK CONDITION IS CONSISTENT WITH THE EXPECTATIONS OF INSERTION WITH EXCESSIVE FORCE OR POWER TOOLS. IT IS LIKELY THAT THE METHOD OF USE AND/OR THE USE OF WORN COMPONENTS RATHER THAN A DESIGN DEFICIENCY HAS LED TO THIS PORTION OF THE COMPLAINT. COMPLAINT CATEGORY OF ¿BROKE¿ ADDRESSES THE BROKEN UNKNOWN SCREW HEAD. GIVEN THE FORCE REQUIRED TO INSERT THE SCREW EXTRACTOR TO THE POINT OF SEIZING, IT IS MOST LIKELY THAT THE SCREW BROKE AFTER OR WHILE THE SCREW EXTRACTOR WAS INSERTED. THE LIKELY CAUSE OF THE BROKEN CONDITION IS THAT THE EXTRACTION OF THE UNKNOWN SCREW HAD TO OVERCOME OSSEOINTEGRATION. THUS, IT APPEARS THAT MECHANICAL OVERLOAD DURING THE DESCRIBED EXTRACTION CAUSED THIS BREAKAGE. HOWEVER, WITHOUT ADDITIONAL INFORMATION REGARDING THE UNKNOWN SCREW AND THE TIME FRAME OF THE BREAK, THIS COMPLAINT IS INDETERMINATE.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    (B)(4) WAS RECEIVED ON (B)(6) 2013 AND ONLY CORRECTED AND ADDITIONAL INFORMATION WILL BE PROVIDED. THE USER FACILITY MEDWATCH IS ATTACHED. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288817 UNK - SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1