BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING, 36MM

    MDR report key: 2841299 · Received November 1, 2012

    Report

    Report Number
    2520274-2012-02829
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 4, 2012
    Manufacturer
    SYNTHES INC
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER: DETERMINED DURING THE INVESTIGATION. THIS SCREW WAS RECEIVED WHOLE AND INTACT. THIS SCREW APPEARS TO BE A SELF-TAPPING CORTEX SCREW. IF SO, THE MAJOR DIAMETER OF 4.33MM AND LENGTH OF 36MM LENGTH WOULD MAKE THIS A 214.836. THE HEX DRIVE HAS LIGHT MARKINGS, CONSISTENT WITH NORMAL USE. THE TOP OF THE HEAD IS IN GOOD CONDITION. THE BAND HAS SOME SLIGHT MARKINGS THAT APPEAR TO BE GALLING. THE BOTTOM OF THE HEAD HAS A WEAR MARK WITH LOCALIZED GALLING SUFFICIENT TO CAUSE SOME MATERIAL LOSS. SOME BIO MATERIAL REMAINS AT THE BOTTOM OF THE HEAD ALSO. THE THREAD MAJOR DIAMETER HAS BEEN FLATTENED INTO THE SHAPE OF A "L" WHICH AFFECTS THE THREAD PROFILE FOR NEARLY THE ENTIRE LENGTH OF THE SHAFT. THE TIP AND FLUTES ARE IN GOOD CONDITION. THE DIMENSIONS THAT COULD BE MEASURED ARE WITHIN SPECIFICATION. A REVIEW OF THE DESIGN, COMPLAINT HISTORY AND RISK ANALYSIS INDICATES THAT THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. BONY UNION IS DEPENDENT ON A MULTITUDE OF FACTORS, SUCH AS PROPER REDUCTION, BONE QUALITY, PATIENT COMPLIANCE, IMPLANT SELECTION, ETC. THE LACK OF ADDITIONAL INFORMATION PREVENTS A COMPLETE ANALYSIS OF THE CAUSE OF FAILURE. ADDITIONALLY, THE PATIENTS FALL MAY HAVE CAUSED A RE-FRACTURE.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. ADDITIONAL INFORMATION: DATE OF REPORT: (B)(4)2012, DEVICE INFO: COMPRESSION SCREW, 4 HOLE SIDEPLATE, SCREWS, DATE OF PRODUCT RETURN: (B)(4) 2012, (B)(6).

    Description of Event or Problem · 1

    (B)(4), A COPY WILL BE INCLUDED WITH THE REPORT. THIS IS 6 OF 7 REPORTS FOR THIS EVENT. ADDITIONAL INFORMATION: PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AFTER HAVING FALL AT HOME. THE PT ORIGINALLY HAD SURGERY ON (B)(6) 2011 FOR INTERTROCHANTERIC RIGHT HIP FRACTURE. AT THAT TIME THE PT HAD A SYNTHES COMPRESSION HIP SCREW PLACED. THE ORIGINAL SURGERY USED KIRSCHNER WIRE PLACED INTO THE FEMORAL NECK AND HEAD. LAG SCREW OF 90MM USED. COMPRESSION SCREW PLACED ALONG WITH 4-HOLE SIDEPLATE WHICH WAS 135-DEGREE SIDEPLATE. WAS ATTACHED USING STANDARD TECHNIQUE AND THE COMPRESSION SCREW WAS THEN APPLIED. NO OTHER INFORMATION WAS FOUND EXCEPT NUMBERS ON DEVICES. SURGERY WAS PERFORMED ON (B)(6) 2012 FOR CONVERSION TO HIP REPLACEMENT DUE TO "NONUNION OF INTERTROCHANTERIC FRACTURE OF HIP". THE APPARATUS WAS REMOVED AND IT WAS DOCUMENTED AS OBVIOUS THAT THERE WAS A NONUNION AT THE FEMORAL NECK AND ALSO AT 50% OF THE GREATER TROCHANTER. THE NONUNION MATERIAL WAS MOVED AS NEEDED. THE PT TOLERATED THE PROCEDURE WELL AND DISCHARGED HOME ON (B)(6) 2012. TOTAL ITEMS SENT BACK TO MANUFACTURER 5 SCREWS, COMPRESSION SCREW, 4-HOLE SIDEPLATE. ITEM NUMBERS AS FOLLOWS: COMPRESSION SCREW=DHS (B)(4), 90MM, (B)(4); 4-HOLE SIDEPLATE NUMBERS-DHS (B)(4), 135 DEGREES, (B)(4) SCREWS WITH NO IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW SELF-TAPPING, 36MM 4.5MM CORTEX SCREW SELF-TAPPING, 36MM HWC SYNTHES INC UK-SEE NOTES UK-SEE NOTES

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R PLATE| LAG SCREW| SCREWS