BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 130°

    MDR report key: 4100415 · Received September 19, 2014

    Report

    Report Number
    0009610622-2014-00473
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 13, 2014
    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

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

    Additional Manufacturer Narrative · 1

    THE REVIEW OF MANUFACTURING DOCUMENTS REVEALED NO DEVIATION IN THE MANUFACTURING PROCESS. DIMENSIONAL EXAMINATION REVEALED NO DEFICIENCY. FUNCTION WAS NO LONGER GIVEN DUE TO BREAKAGE. THE FRACTURE PATTERN OF THE NAIL SUGGESTED THAT THE NAIL HAD BROKEN IN FATIGUE MANNER AFTER AN IMPLANTATION PERIOD OF APPROX.3 MONTHS. THE BREAKAGE HAD STARTED WITH AN INCIPIENT CRACK AT LATERAL IN THE POSTERIOR BRIDGE. THE CRACK HAD PROGRESSED EVENLY THROUGH THE CROSS SECTION TOWARDS MEDIAL AND ENDED IN A SMALL RESIDUAL FRACTURE. THE CRACK IN THE ANTERIOR BRIDGE HAD MOST LIKELY STARTED WITH DELAY BUT PROGRESSED IN THE SAME MANNER. ALTHOUGH COATING HAD BEEN REMOVED BY DRILLING INSIDE THE PROXIMAL DRILL HOLE IT COULD NO LONGER BE DETERMINED WHETHER DRILL MARKS IN THE LATERAL EDGE HAD CONTRIBUTED TO THE ORIGIN OF THE CRACK. HOWEVER, OVERLAYING STRESSES IN THE AREA OF THE INCIPIENT CRACK MAY HAVE CONTRIBUTED TO THE START OF THE CRACK. THE APPEARANCE OF THE BEARING POINTS ¿ SEIZED, DEFORMED, WORN MATERIAL ¿ ON LAG SCREW AND INSIDE THE NAIL¿S DRILL HOLES IDENTIFIED SIGNIFICANT AXIAL LOAD APPLICATION. HIGH LOAD APPLICATION HAD CONTRIBUTED TO SEIZING ON THE LAG SCREW. CONSEQUENTLY, HIGH LOAD MAY HAVE CONTRIBUTED TO THE ORIGIN OF AN INCIPIENT CRACK AT LATERAL. REFERRING TO AVAILABLE INFORMATION A MORE PRECISE STATEMENT WAS NOT POSSIBLE FROM TECHNICAL POINT OF VIEW. REFERRING TO MEDICAL REVIEW RECEIVED X-RAYS PRESENTED AN UNSTABLE COMMINUTED SUBTROCHANTERIC FEMUR FRACTURE WITH EXTENSION TO THE PROXIMAL PART OF THE FEMUR SHAFT HAVING A LARGE MEDIAL BUTTERFLY FRAGMENT AND AN AVULSION OF THE LESSER TROCHANTER RESULTING IN A DEFICIENT MEDIAL PILLAR WITH INSUFFICIENT BONE CONTACT. THE LATERAL END OF THE GAMMA LAG SCREW WAS NOT PLACED IN THE DISTAL MAIN FRAGMENT RESULTING IN A DEFICIENT LATERAL PILLAR. THE RECEIVED X-RAYS SHOWED A DEFECT MEDIAL PILLAR AND A DEFECT LATERAL PILLAR AS WELL. WITH SUCH A POOR FRACTURE CONSTELLATION, THE GAMMA-NAIL (OR A COMPARABLE COMPETITIVE PRODUCT) WAS NOT INTENDED FOR EARLY AND LONG TERM FULL WEIGHT BEARING. IN THE SURGICAL PROTOCOL FROM (B)(6) 2014 NO WEIGHT BEARING LIMITATIONS ARE MENTIONED. CURRENTLY, NO INFORMATION HAS BEEN PROVIDED ON THE REAL POSTOPERATIVE WEIGHT BEARING OF THE (B)(6) PATIENT, BUT THE EARLY BREAKAGE INDICATES THAT WEIGHT BEARING HAS NOT BEEN SIGNIFICANTLY LIMITED IN THE GIVEN CASE. CONSIDERING THE TECHNICAL FINDINGS ¿ SEIZED, DEFORMED, WORN MATERIAL ¿ THE CONCLUSION OF THE MEDICAL REVIEW APPEARED TO BE APPLICABLE. THE NAIL BROKE IN A FATIGUE FRACTURE DUE TO OVERLOAD. A POOR FRACTURE CONSTELLATION AND EARLY HIGH WEIGHT BEARING HAD MOST LIKELY CONTRIBUTED TO THE ORIGIN OF THE INCIPIENT CRACK. THUS, EARLY IMPLANT BREAKAGE WAS RATHER FORESEEABLE AS STATED IN THE LITERATURE. IN CASE FURTHER RELEVANT INFORMATION SHOULD BECOME AVAILABLE, WE RESERVE THE RIGHT TO UPDATE THE INVESTIGATION AND CHANGE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON THAT THE NAIL IS BROKEN. NAIL WAS IMPLANTATION ON (B)(6) 2014 AND REVISED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON THAT THE NAIL IS BROKEN. NAIL WAS IMPLANTATION ON (B)(6) 2014 AND REVISED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585073 LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K112813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention