BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED S2 Ø5X50 MM

    MDR report key: 3106743 · Received May 10, 2013

    Report

    Report Number
    0009610622-2013-00247
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEFICIENCIES WERE FOUND DURING REVIEW OF THE MANUFACTURING DOCUMENTS, NEITHER FOR THE FEMORAL NAIL NOR FOR THE LOCKING SCREW. ACCORDING TO THE RECEIVED INFORMATION THE NAIL BROKE AFTER AN IMPLANTATION PERIOD OF APP. 6 MONTHS. AFTER AN IMPLANTATION PERIOD OF 6 MONTHS THE FRACTURE SHOULD HAVE BEEN HEALED, OR AT LEAST THERE SHOULD HAVE BEEN SIGNIFICANT BONY CONSOLIDATION AROUND THE FRACTURE SITE. ACCORDING TO THE ONLY AVAILABLE X-RAYS THIS COULD NOT BE CONFIRMED. THE LOCKING SCREW WITH CAT. # 17965050S IS REGARDED AS CONCOMITANT PRODUCT, AND THE EVENT OF SCREW BREAKAGE HAS TO BE EXAMINED IN CORRELATION WITH THE BREAKAGE OF THE FEMORAL NAIL WITH CAT. # 17351138S. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICES. WITH RESPECT TO THE INFORMATION AVAILABLE WE CONCLUDE THAT THE NAIL AND SCREW BROKE DUE TO LONG TERM OVERLOADING MOST LIKELY CAUSED BY DELAYED UNION OF THE BONE FRACTURE. DUE TO MISSING INFORMATION SUCH AS ANY X-RAYS TAKEN PRE-, INTER- AND POSTOPERATIVE OR ANY OTHER MEDICAL RECORDS TO DETERMINE CORRECT INDICATION, CORRECT REDUCTION, CORRECT IMPLANT PLACEMENT AS WELL AS THE ABSENCE OF ANY PATIENT DATA A MORE PRECISE STATEMENT REGARDING THE ROOT CAUSE OF THE EVENT IS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO SALES REP THAT A PATIENT WITH A FEMORAL NAIL IMPLANTED IN (B)(6) 2012 CLAIMED AN INSTABILITY OF FEMUR. X-RAYS SHOWED THAT FEMORAL STEM HAD BEEN BROKEN. THE REVISION IS SCHEDULED FOR TUESDAY NEXT WEEK.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO SALES REP THAT A PATIENT WITH A FEMORAL NAIL IMPLANTED IN (B)(6) 2012 CLAIMED AN INSTABILITY OF FEMUR. X-RAYS SHOWED THAT FEMORAL STEM HAD BEEN BROKEN. THE REVISION IS SCHEDULED FOR TUESDAY NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207839 LOCKING SCREW, FULLY THREADED S2 Ø5X50 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K160508

    Patients

    Seq Age Sex Outcome Treatment
    1 Other