BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING RECONSTRUCTION PLATE AXSOS 6 HOLE / L72MM 4.0MM LOCKING SET

    MDR report key: 4220261 · Received November 3, 2014

    Report

    Report Number
    0008031020-2014-00521
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    June 6, 2013
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K060798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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: THE REPORTED EVENT OF THE BROKEN PLATE FOR LOCKING RECONSTRUCTION PLATE AXSOS 6 HOLE / L72MM 4.0MM LOCKING SET COULD NOT CONFIRMED. BASED ON THE INVESTIGATION, IT WAS NOT POSSIBLE TO ATTRIBUTE TO THE ROOT CAUSE. NOT ENOUGH INFORMATION HAS BEEN PROVIDED TO IDENTIFY THE FAILURE MODE AND THE ROOT CAUSE OF THE COMPLAINT. INFORMATION SUCH AS MEDICAL RECORDS, PHOTOS OF THE DEVICES, IMPLANT SHEET, SURGEONS FOLLOW UP, X-RAYS (2 VIEWS) WOULD HAVE BEEN NECESSARY TO ASSESS THE COMPLAINT. "THESE DEVICES ARE INTENDED ONLY TO ASSIST HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BONE STRUCTURES. NO FRACTURE FIXATION DEVICE THAT IS SUBJECT TO MATERIAL FATIGUE CAN BE EXPECTED TO WITHSTAND ACTIVITY LEVELS IN THE SAME WAY AS WOULD A NORMAL HEALTHY BONE. THE FRACTURE FIXATION SYSTEM, THEREFORE, WILL NOT BE AS STRONG, RELIABLE OR DURABLE AS A NORMAL HUMAN BONE. ENSURE THAT YOU ARE FAMILIAR WITH THE INTENDED USES, INDICATIONS/CONTRAINDICATIONS, COMPATIBILITY AND CORRECT HANDLING OF THE IMPLANT, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. PLEASE REMEMBER THAT PRODUCT SYSTEMS MAY BE SUBJECT TO ALTERATIONS THAT AFFECT THE COMPATIBILITY OF THE IMPLANT WITH OTHER IMPLANTS OR WITH INSTRUMENTS. FOR YOUR INFORMATION, AVAIL YOURSELF OF THE TRAINING COURSES AND PUBLICATIONS OFFERED." (V15013 K NON ACTIVE IMPLANT IFU) [ORIGINAL STATEMENT] "POST-OPERATIVE ¿ POST-OPERATIVE PATIENT ACTIVITY: THESE IMPLANTS ARE NEITHER INTENDED TO CARRY THE FULL LOAD OF THE PATIENT ACUTELY, NOR INTENDED TO CARRY A SIGNIFICANT PORTION OF THE LOAD FOR EXTENDED PERIODS OF TIME. FOR THIS REASON POST-OPERATIVE INSTRUCTIONS AND WARNINGS TO PATIENTS ARE EXTREMELY IMPORTANT. EXTERNAL IMMOBILIZATION (E.G. BRACING OR CASTING) MAY BE EMPLOYED UNTIL X-RAYS OR OTHER PROCEDURES CONFIRM ADEQUATE BONE CONSOLIDATION. [...] THE RISK OF POST-OPERATIVE COMPLICATION (E.G. FAILURE OF AN IMPLANT) IS HIGHER IF PATIENTS ARE OBESE AND/OR CANNOT FOLLOW THE RECOMMENDATIONS OF THE PHYSICIAN BECAUSE OF ANY MENTAL OR NEUROMUSCULAR DISORDER. FOR THIS REASON THOSE PATIENTS MUST HAVE ADDITIONAL POST-OPERATIVE FOLLOW-UP." (V15013 K NON ACTIVE IMPLANT IFU) [ORIGINAL STATEMENT] "INFORMING THE PATIENT THE IMPLANTATION AFFECTS THE PATIENT¿S ABILITY TO CARRY LOADS AND HER/HIS MOBILITY AND GENERAL LIVING CIRCUMSTANCES. FOR THIS REASON, THE SURGEON MUST COUNSEL EACH PATIENT INDIVIDUALLY ON CORRECT BEHAVIOR AND ACTIVITY AFTER THE IMPLANTATION. THE SURGEON MUST WARN PATIENT THAT THE DEVICE CANNOT AND DOES NOT REPLICATE A NORMAL HEALTHY BONE, THAT THE DEVICE CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY, TRAUMA, MAL-UNION OR NON-UNION AND THAT THE DEVICE HAS A FINITE EXPECTED SERVICE LIFE AND MAY NEED TO BE REMOVED AT SOME TIME IN THE FUTURE. EXPLAIN THE NEED TO REPORT UNUSUAL CHANGES IN THE IMPLANTATION AREA AS WELL AS FALLS OR ACCIDENTS EVEN IF THE DEVICE OR THE SITE OF OPERATION DID NOT APPEAR TO BE HARMED AT THE TIME." (V15013 K NON ACTIVE IMPLANT IFU) [ORIGINAL STATEMENT] "ADVERSE EFFECTS IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EFFECTS INVOLVING THE USE OF INTERNAL FRACTURE FIXATION DEVICES: [...] THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NON-UNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE. CONDITIONS ATTRIBUTABLE TO NON-UNION, OSTEOPOROSIS, OSTEOMALACIA, DIABETES, INHIBITED REVASCULARIZATION AND POOR BONE FORMATION CAN CAUSE LOOSENING, BENDING, CRACKING, FRACTURE OF THE DEVICE OR PREMATURE LOSS OF RIGID FIXATION WITH THE BONE." (V15013 K NON ACTIVE IMPLANT IFU) [ORIGINAL STATEMENT] THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION OF A DISPLACED LEFT ULNA FRACTURE FOLLOWING A MOTOR VEHICLE ACCIDENT WITH A SIX HOLE PLATE ALONG WITH LOCKING SCREWS. IT IS ALLEGED "IN (B)(6) 2013 THE PATIENT EXPERIENCED PAIN IN HIS FOREARM AFTER SLEEPING. IT WAS FURTHER NOTED THAT ALL SCREWS WERE STILL PROPERLY FIXED WITHIN THE ULNA, AND THAT THE PLATE HAD SIMPLY BROKEN." THE PLATE WAS REVISED ON "(B)(6), 204" WITH A TEN HOLE PLATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION OF A DISPLACED LEFT ULNA FRACTURE FOLLOWING A MOTOR VEHICLE ACCIDENT WITH A SIX HOLE PLATE ALONG WITH LOCKING SCREWS. IT IS ALLEGED "IN (B)(6) 2013 THE PATIENT EXPERIENCED PAIN IN HIS FOREARM AFTER SLEEPING. IT WAS FURTHER NOTED THAT ALL SCREWS WERE STILL PROPERLY FIXED WITHIN THE ULNA, AND THAT THE PLATE HAD SIMPLY BROKEN." THE PLATE WAS REVISED ON (B)(6) 204 WITH A TEN HOLE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702024 LOCKING RECONSTRUCTION PLATE AXSOS 6 HOLE / L72MM 4.0MM LOCKING SET PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH W14242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention