BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, TI GAMMA3 Ø10.5X90MM

    MDR report key: 3166893 · Received June 13, 2013

    Report

    Report Number
    0009610622-2013-00329
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICES REPORTED WERE NOT RETURNED TO STRYKER (B)(4). THUS, DEVICE INSPECTION WAS IMPOSSIBLE. HOWEVER, THE REPORTED EVENT (ORIGINAL TEXT TRANSLATED FROM DANISH TO ENGLISH: ¿THE LAG SCREW HAS PERFORATED THE FEMORAL HEAD AND THE PELVIS AND NOW SITS HALFWAY INTO THE PELVIS¿) WAS CONFIRMED BY THE X-RAYS RECEIVED. NO DEVIATION WAS FOUND IN THE MANUFACTURING DOCUMENTS OF THE LAG SCREW, LONG NAIL AND SET SCREW. THE ROOT CAUSE OF THE DISLOCATION OF THE LAG SCREW INTO THE SMALL PELVIS WAS ALREADY GIVEN IN THE ORIGINAL EVENT DESCRIPTION, WHICH WAS TRANSLATED FROM DANISH (¿¿SKYLDES FORMENTLIG, AT EN LILLE LÅSESKRUE IKKE HAR VÆRET RIGTIG I INDHAK I EN RILLE¿¿) TO ENGLISH (¿¿THIS WAS PROBABLY CAUSED BY THE INSUFFICIENTLY INSERTED SMALL (SET) SCREW INTO THE GROOVE¿¿). THE ABOVE STATEMENT IS SUPPORTED BY THE RELEVANT X-RAYS ; THE POSITION OF THE FACE SIDE OF THE SET SCREW INDICATES THAT THE ROUNDED TIP DID NOT EVEN REACH THE LATERAL / CONVEX SURFACE OF THE LAG SCREW, MUCH LESS THE GROUND OF A GROOVE. THE INFORMATION RECEIVED INCLUDING THE X-RAYS WERE FORWARDED TO A MEDICAL EXPERT FOR REVIEW WHO CONFIRMED THE INSUFFICIENT INSERTION / INCORRECT POSITION OF THE SET SCREW ACCORDING TO THE X-RAYS PROVIDED. BASED ON THE ABOVE FACTS IT CAN BE ASSUMED THAT IN THIS CASE THE CENTRAL MIGRATION OF THE LAG SCREW WAS CAUSED BY AN INSUFFICIENTLY INSERTED SET SCREW, WHICH COULD HAVE BEEN DETECTED BY THE SURGEON ACCORDING TO GAMMA3 OPERATION TECHNIQUE. THUS, THE REPORTED EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE(S), BUT IS RATHER RELATED TO A DEVIATION FROM SURGICAL TECHNIQUE. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE CASE PRESENTS A MIGRATION OF A GAMMA3 LAG SCREW, NOT A NAIL BREAKAGE (ORIGINALLY ALLEGED). TO DATE, IT IS NOT CLEAR WHETHER THE DEVICES WILL BE AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CASE PRESENTS A MIGRATION OF A GAMMA3 LAG SCREW, NOT A NAIL BREAKAGE (ORIGINALLY ALLEGED). TO DATE, IT IS NOT CLEAR WHETHER THE DEVICES WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268295 LAG SCREW, TI GAMMA3 Ø10.5X90MM IMPLANT HSB STRYKER TRAUMA KIEL K573647

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention