BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°

    MDR report key: 3056668 · Received April 12, 2013

    Report

    Report Number
    0009610622-2013-00190
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION REVEALED THE LONG GAMMA NAIL TO BE THE PRIMARY PRODUCT. ALL OTHER MENTIONED PRODUCTS ARE REGARDED TO BE CONCOMITANT ITEMS. THE RETURNED DEVICE MATCHED THE REPORT, AND THE INCIDENT WAS CONFIRMED. INVESTIGATION REVEALED NO DISCREPANCIES IN MATERIAL OF MANUFACTURING. ACCORDING TO THE DAMAGE AND THE EVIDENCES OF THE BREAKAGE SURFACES THE NAIL BROKE IN A FATIGUE FRACTURE DUE TO OVERLOAD, CONTRIBUTED BY INTRA OPERATIVELY DAMAGE OF THE NAIL CAUSED BY A DEVIATED LAG SCREW STEP DRILL. DUE TO A NOTCHING EFFECT, THE MISDRILL MOST LIKELY HAD CREATED THE STARTING POINT OF THE IMPLANT BREAKAGE AT THE LATERAL EDGE OF THE ANTERIOR BRIDGE. EVENT DESCRIPTION CONFIRMED A HYPERTROPHIC NONUNION. CONSEQUENTLY, THE NAIL WAS NOT RELIEVED BY BONE CONSOLIDATION AND HAD TO ABSORB THE COMPLETE LOAD APPLICATION DURING THE IMPLANTATION PERIOD. INCREASING AND / OR PERMANENT LOAD APPLICATION WILL INEVITABLY LEAD TO FATIGUE OF MATERIAL. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO HIGH LOAD APPLICATION BY THE PATIENT CONTRIBUTED BY INTRA OPERATIVE DAMAGE OF THE PROXIMAL DRILL HOLE. A MORE PRECISE STATEMENT IS NOT POSSIBLE WITH THE INFORMATION GIVEN.

    Description of Event or Problem · 1

    HYPERTROPHIC NON-UNION, CABLE AROUND PROXIMAL THIRD OF FEMUR. REVISION OP DATE: (B)(6) 2013. REMOVAL OF ITEM 11X380 125 DEGREES RIGHT 3225-0380, K111550 BROKEN THROUGH LAG SCREW HOLE. FLEXION AT PROXIMAL SEGMENT ON INITIAL OP. ORIGINAL OP DATE (B)(6) 2012.

    Description of Event or Problem · 1

    HYPERTROPHIC NON-UNION, CABLE AROUND PROXIMAL THIRD OF FEMUR. REVISION OP DATE: (B)(6) 2013. REMOVAL OF ITEM 11X380 125 DEGREES RIGHT 3225-0380, K111550 BROKEN THROUGH LAG SCREW HOLE. FLEXION AT PROXIMAL SEGMENT ON INITIAL OP. ORIGINAL OP DATE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157493 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K111550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention