BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 2991786 · Received March 6, 2013

    Report

    Report Number
    0002249697-2013-00928
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING AN ADM EXPANDABLE COUPLER WAS REPORTED. THE EVENT WAS CONFIRMED. THE RETURNED RESTORATION ADM MANCHON EXPANS WAS BROKEN INTO THREE SECTIONS. IT APPEARS THAT ALL OF THE FRACTURES INITIATED ON THE MACHINED RADIUS THE FLAT OUTER SURFACE AND PROGRESSED TOWARDS THE FLAT OUTER SURFACE FROM AN OVERLOAD CONDITION. THE MAR CONCLUDED THAT THE RESTORATION ADM MANCHON EXPANS BROKE FROM AN OVERLOAD CONDITION. THE FRACTURES INITIATED ON THE MACHINED RADIUS AND PROGRESSED TOWARDS THE FLAT OUTER SURFACE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS ANALYSIS. THE REVIEW INDICATED THAT ALL REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. WHILE THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, THE MAR CONCLUDED THAT THE RESTORATION ADM MANCHON EXPANS BROKE FROM AN OVERLOAD CONDITION. THE FRACTURES INITIATED ON THE ON THE MACHINED RADIUS AND PROGRESSED TOWARDS THE FLAT OUTER SURFACE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS ANALYSIS. AS STATED IN THE SURGICAL PROTOCOL, IF RE-IMPACTION IS REQUIRED, BE SURE TO USE THE SAME EXPANDABLE COUPLER SIZE AS THE FINAL IMPLANT. DO NOT USE A SMALLER EXPANDABLE COUPLER SIZE THAN THE FINAL IMPLANT AS THIS WILL COMPROMISE THE INTEGRITY OF THE COUPLER, AND MAY CAUSE IT TO BREAK. IN THE EVENT DESCRIPTION, IT IS STATED THAT THE CUP IMPACTOR WAS USED FOR A FINAL IMPACTION OF THE ADM CUP AND A BREAKAGE OCCURRED. THE SALES REP WAS TOLD THAT POSSIBLY A SMALLER ADM CUP INTRODUCER WAS SELECTED FOR FINAL IMPACTION. IT IS POSSIBLE THAT THE SELECTION OF THE SMALLER EXPANDABLE COUPLER SIZE RELATIVE TO THE CUP SIZE COULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUP IMPACTOR WAS USED FOR A FINAL IMPACTION OF THE ADM CUP AND A BREAKAGE OCCURRED. THE REP INDICATED THAT IT WAS EXPLAINED THAT POSSIBLY A SMALLER ADM CUP INTRODUCER WAS SELECTED FOR FINAL IMPACTION AND THIS POSSIBLY CONTRIBUTED TO THE OUTCOME. THERE WAS A 5 MIN DELAY IN SURGERY.

    Description of Event or Problem · 1

    THE CUP IMPACTOR WAS USED FOR A FINAL IMPACTION OF THE ADM CUP AND A BREAKAGE OCCURRED. THE REP INDICATED THAT IT WAS EXPLAINED THAT POSSIBLY A SMALLER ADM CUP INTRODUCER WAS SELECTED FOR FINAL IMPACTION AND THIS POSSIBLY CONTRIBUTED TO THE OUTCOME. THERE WAS A 5 MIN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95918 RESTORATION ADM MANCHON EXPANS INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3034492

    Patients

    Seq Age Sex Outcome Treatment
    1 Other