BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, STST GAMMA3® Ø10.5X100MM

    MDR report key: 4180038 · Received October 17, 2014

    Report

    Report Number
    0009610622-2014-00559
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 23, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE LAG SCREW, STST GAMMA3 Ø10.5X100MM IS STATED TO BE THE PRIMARY PRODUCT. THE TROCHANTERIC NAIL KIT AND THE LOCKING SCREW ARE CONSIDERED ASSOCIATED PRODUCTS. FAILURES IN MATERIAL OR MANUFACTURING OF THE AFFECTED LAG SCREW RETURNED WERE NOT FOUND. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS OF THE LAG SCREW. THE AFFECTED ITEM REPORTED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. THE RETURNED LAG SCREW IS COMPLETELY BROKEN IN THE MINOR DIAMETER AT THE LEVEL WHERE THE CONE CHANGES TO STRAIGHT. MACROSCOPIC EXAMINATION OF THE BREAKAGE SURFACES REVEALED EVIDENCE THAT THE LAG SCREW BROKE IN A FATIGUE FRACTURE DUE TO AXIAL OVERLOAD AFTER AN IMPLANTATION PERIOD OF 7 MONTHS. THE AFFECTED IMPLANTS ARE DESIGNED TO WITHSTAND THE NORMAL LOADS DURING THE IMPLANTATION PERIOD, I.E., THE IMPLANT MUST NEITHER BE EXPOSED TO PEAK LOADS NOR TO CONTINUOUS STRESSES. ANOTHER PREREQUISITE FOR A SUCCESSFUL SUPPLY IS UNDISTURBED, NORMAL BONE HEALING. THIS STATE MUST BE ACHIEVED WITHIN A MEDICALLY RECOGNIZED AND BY SCIENTIFIC ANALYSIS CONFIRMED PERIOD (ABOUT 6 MONTHS) IN SUCH WAY, THAT THE BONE STRENGTH ALLOWS SIGNIFICANTLY INCREASING DISCHARGE OF THE TIME-FIXED IMPLANT MATERIAL. IN CASE THAT SUCH A SITUATION DOES NOT OCCUR, EXCEEDING OF THE FATIGUE STRENGTH IS TO BE EXPECTED AND THUS QUITE PREDICTABLE COMPLICATIONS. MATERIAL DEFORMATION (FRICTION MARKS) AT THE MEDIAL / DISTAL AND THE LATERAL / PROXIMAL EDGE OF THE LAG SCREW THROUGH HOLE INDICATES HIGH TENSION FORCES CAUSED BY HIGH AXIAL LOAD - TRANSMITTED BY THE LAG SCREW, WHICH SUGGESTS MORE THAN PARTIAL WEIGHT BEARING. THE COUNTERPARTS WERE FOUND ON THE LAG SCREW IN THE AREAS WITH FRICTION MARKS WHERE THE EDGES OF THE SLIDING GROOVES HAD BECOME WORN. IN ABSENCE OF MEDICAL RECORDS / SURGERY REPORTS AND X-RAYS THE KIND OF BONE BREAKAGE CANNOT BE DETERMINED. DUE TO MISSING PATIENT DATA IT COULD NOT BE DETERMINED TO WHAT EXTENT THE PATIENT¿S WEIGHT AND THE PATIENT¿S COMPLIANCE MAY HAVE CONTRIBUTED TO THE EVENT. NEVERTHELESS, THE IMPLANTATION PERIOD OF 7 MONTHS SUGGESTS THAT INSUFFICIENT BONE HEALING MAY HAVE CONTRIBUTED TO THE SCREW BREAKAGE. RECONSTRUCTION OF THE POSITION OF THE LOCKING SCREW DURING THE IMPLANTATION PERIOD BASED ON THE TRACES FOUND ON THE IMPLANTS REVEALED THAT THE LOCKING SCREW HAD NOT BEEN INSERTED TO THE INTENDED POSITION, BUT HAD RATHER BEEN SCREWED BESIDE THE NAIL. BASED ON AVAILABLE INFORMATION AND ON ABOVE OBSERVATIONS THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE. NO NON-CONFORMITY WAS IDENTIFIED.

    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 BY THE PHARMACIST AND RISK MANAGER AT THE HOSPITAL: "IMPLANTATION ON (B)(6) 2013 OF A STRYKER NAIL. PATIENT CAME TO THE EMERGENCY ROOM ON (B)(6) 2014 FOR GROIN PAIN. X-RAY REVEALED THE FRACTURE OF THE LAG SCREW. OSTEOSYNTHESIS MATERIAL REMOVED AND IMPLEMENTATION OF AN INTERMEDIATE HEMI-ARTHROPLASTY OF THE RIGHT HIP, DESPITE THE YOUNG AGE OF THE PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHARMACIST AND RISK MANAGER AT THE HOSPITAL: "IMPLANTATION ON (B)(6), 2013 OF A STRYKER NAIL. PATIENT CAME TO THE EMERGENCY ROOM ON (B)(6), 2014 FOR GROIN PAIN. X-RAY REVEALED THE FRACTURE OF THE LAG SCREW. OSTEOSYNTHESIS MATERIAL REMOVED AND IMPLEMENTATION OF AN INTERMEDIATE HEMI-ARTHROPLASTY OF THE RIGHT HIP, DESPITE THE YOUNG AGE OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662928 LAG SCREW, STST GAMMA3® Ø10.5X100MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K06433D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention