BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X280MM X 125°

    MDR report key: 3200832 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00365
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DEVIATIONS IN THE MANUFACTURING DOCUMENTS AND THE MATERIAL WERE NOT FOUND. THE LOT WAS DOCUMENTED AS MEETING SPECIFICATIONS PRIOR TO DISTRIBUTION. APPEARANCE OF THE BREAKAGE SURFACES OF THE NAIL SUCH AS LINES OF REST AND MISSING PLASTIC DEFORMATION IDENTIFY A FATIGUE FRACTURE. THE FEATURES OF THE BREAKAGE SURFACES OF THE NAIL INDICATE THAT THE BREAKAGE STARTED AT THE LATERAL EDGE OF THE POSTERIOR BRIDGE. THE NAIL HAS BEEN INTRA-OPERATIVELY DAMAGED BY A DEVIATED LAG SCREW STEP DRILL. DUE TO A NOTCHING EFFECT, THE MISDRILLING HAD CREATED THE STARTING POINT OF THE IMPLANT BREAKAGE AT THE EDGE OF THE POSTERIOR BRIDGE. IN THE FOLLOWING THE FRACTURE WAS RUNNING THROUGH THE CROSS SECTIONS, THEN PROGRESSED BY INCREASING TORSIONAL AND TENSIONAL LOAD APPLICATION THROUGH THE POSTERIOR BRIDGE FROM LATERAL TO MEDIAL AND FINALLY ENDED IN A RESIDUAL FRACTURE AT MEDIAL. THE BREAKAGE OF THE ANTERIOR BRIDGE FOLLOWED THEN IN A MUCH QUICKER WAY WITH EXTREMELY HIGH TORSIONAL AND TENSIONAL LOAD. MARKINGS AT THE DISTAL / MEDIAL AND AT THE PROXIMAL / LATERAL EDGES OF THE PROXIMAL DRILL HOLE ARE IDENTIFIED AS BEARING POINTS OF THE LAG SCREW. THEY WERE CAUSED BY (MICRO-) MOVEMENTS THAT INDUCED BEARING FRICTION BETWEEN LAG SCREW AND NAIL DURING THE IMPLANTATION PERIOD. THE COUNTERPARTS WERE FOUND ON THE LAG SCREW IN THE AREAS WITH FRICTION SIGNS WHERE THE EDGES OF THE SLIDING FLUTES HAD BECOME WORN. GENERAL TECHNICAL ASPECT: THE BROKEN NAIL IS A TEMPORARY IMPLANT WHICH INEVITABLY WILL BE SUBJECT OF A FATIGUE FRACTURE IF THE STRESSES ON THE IMPLANT ARE TOO HIGH OR NOT CONSIDERABLY REDUCED DURING THE PERIOD OF IMPLANTATION. DURING THE IMPLANTATION PERIOD THE WEAKENED (DAMAGED) NAIL HAD TO ABSORB THE COMPLETE LOAD APPLICATION. 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 OVERLOADING BY THE PATIENT CONTRIBUTED BY INTRA-OPERATIVE DAMAGE OF THE NAIL BY A DEVIATED STEP DRILL. CONCLUSION OF MEDICAL STATEMENT: DUE TO THE PRESENTED DATA, THE BREAKAGE OF THE GAMMA-NAIL WAS CAUSED BY AN EARLY OVERLOADING IN A COMPLETELY UNSTABLE FRACTURE CONSTELLATION. AN INTRAOPERATIVE DAMAGE OF THE GAMMA NAIL CAUSED BY A DEVIATED STEP DRILL RESULTING IN SIGNIFICANT WEAKENING OF THE GAMMA NAIL IN THE AREA OF THE LAG SCREW THRU HOLE.

    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

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN. THE SURGEON TOOK SOME X-RAYS AND IT WAS NOTICED THAT THE NAIL IS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT CAME IN WITH PAIN. THE SURGEON TOOK SOME X-RAYS AND IT WAS NOTICED THAT THE NAIL IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301575 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X280MM X 125° IMPLANT HSB STRYKER TRAUMA KIEL K144687

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention