BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR HOOK OR SCREW HOLDER

    MDR report key: 3661151 · Received March 5, 2014

    Report

    Report Number
    2530088-2014-10009
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS RECEIVED CONDITION OF DEVICE, PARTIALLY DISASSEMBLED, CAP DETACHED FROM INTERNAL SHAFT. THE REPORTED DEVICE PART WAS RETURNED WITH THE COMPLAINT THAT THE USS HANDLE BROKE WHILE TRYING TO LOAD A USS STICK TO SCREW. PART 388.621 IS A HANDLE FOR HOOK OR SCREW HOLDER FOR USE WITH THE UNIVERSAL SPINE SYSTEM. IT IS USED IN CONJUNCTION WITH THE HOOK OR SCREW HOLDER FOR HOOK AND SCREW PLACEMENT. THE APPLICABLE TECHNIQUE GUIDES OUTLINE THE PROPER METHOD FOR THE USE OF THIS DEVICE. THIS HANDLE FOR HOOK OR SCREW HOLDER WAS RETURNED WITH THE CAP NOT ATTACHED TO THE INTERNAL SHAFT OF THE INSTRUMENT. A REVIEW OF THE MOST CURRENT REVISIONS OF THE DRAWINGS FOR THIS PART WAS PERFORMED AND NO DESIGN CHANGES TO THE HANDLE FOR HOOK OR SCREW HOLDER HAVE BEEN MADE SINCE THIS LOT NUMBER WAS MANUFACTURED IN FEBRUARY 2003. THE MATERIALS USED MAY NOT BE ADEQUATE FOR THE INTENDED USE OF THIS DEVICE, AS THE TECHNIQUE GUIDES AS WELL AS THE DRAWINGS DO NOT INCLUDE INSTRUCTIONS FOR THE DISASSEMBLY OF THIS INSTRUMENT AND EPOXY TECHNOLOGY INC. (EPO-TEK) WAS NOT USED TO MAINTAIN THE PERMANENT POSITIONING OF THE SETSCREW. PER THE TECHNIQUE GUIDES AND THE DRAWINGS, AS THIS DEVICE IS NOT MEANT TO BE DECONSTRUCTED, THE DESIGN IS NOT ENTIRELY ADEQUATE FOR ITS INTENDED USE. AS THERE WAS NO USE OF AN EPOXY AGENT AT THE SET SCREW INTERFACE TO MAINTAIN THE UNITY OF THIS DEVICE, THIS COMPLAINT IS CONFIRMED FROM A PRODUCT DEVELOPMENT VIEWPOINT. 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 USED FOR TREATMENT AND NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NOT COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB EXCHANGE PROCEDURE. THE SURGEON EXCHANGED THE LUMBAR EXTENSION ROD AS IT WAS EXPANDED ALL THE WAY. THE SURGEON APPLIED THE SMALL STATURE RIB HOOK AND NEEDED TO REMOVE IT TO BEND THE LUMBAR EXTENSION MORE. THE HOOK WOULD NOT REMOVE AND THE SURGEON ASSESSED THE SET SCREW WAS BROKEN SOMEHOW. THE SURGEON REMOVED THE ENTIRE DEVICE AND DID NOT REPLACE IT. PRIOR TO THE RIB HOOK THE TABLE TOP CUTTER BROKE AT THE THREAD OF THE HANDLE WHILE CUTTING THE ROD. THE UNIVERSAL SPINE SYSTEM HANDLE BROKE WHILE TRYING TO LOAD A UNIVERSAL SPINE SYSTEM STICK TO SCREW. THERE WAS NO REPORTED PATIENT HARM. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS/OUTCOME IS REPORTED AS SATISFACTORY. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133650 HANDLE FOR HOOK OR SCREW HOLDER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BRANDYWINE 4493928

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR