BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT HALF-PIN APEX HA-COATED Ø 6MM, 200 X 30MM

    MDR report key: 3840159 · Received May 30, 2014

    Report

    Report Number
    0008031020-2014-00261
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    JDW
    PMA / PMN Number
    K061493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE RECEIVED X-RAYS THE REPORTED EVENT OF THE BROKEN AND PULLED OUT PINS COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE OVERLOAD WAS ATTRIBUTED TO A USER RELATED ISSUE. THE RECEIVED INFORMATION AS WELL AS THE RECEIVED X-RAYS WERE REVIEWED BY OUR CLINICAL EXPERT., DIRECTOR R&D, MEDICAL AFFAIRS. HE STATED THAT FOR A PATIENT OVERWEIGHT LIKE THIS 6 TO 8, 6MM PINS IN MINIMUM 2 PLANES WOULD BE INDICATED TO BUILD A RESISTANT CONSTRUCTION. THEREFORE THE OVERLOAD WAS CAUSED BY USING TOO LESS PINS WHICH WERE ALL APPLIED IN ONLY ONE PLANE (UNIPLANAR). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. PLEASE PAY ATTENTION TO THE INSTRUCTIONS FOR USE FOR EXTERNAL FIXATION DEVICES (V15034/G): ¿ATTENTION OPERATING SURGEON THE USE OF EXTERNAL DEVICES PROVIDES THE SURGEON WITH A MEANS OF BONE FIXATION FOR THE MANAGEMENT OF FRACTURE AND RECONSTRUCTIVE SURGERY. THESE DEVICES ARE INTENDED ONLY TO ASSIST HEALING AND ARE NOT INTENDED TO REPLACE NORMAL BONE STRUCTURES. [¿] NO SUCH FRACTURE FIXATION DEVICE, SUBJECT TO FATIGUE, CAN BE EXPECTED TO WITHSTAND ACTIVITY LEVELS IN THE SAME WAY AS WOULD A NORMAL HEALTHY BONE. THE EXTERNAL 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 EXTERNAL FIXATION DEVICES, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. IN USING THESE DEVICES, THE SURGEON SHOULD BE AWARE OF THE FOLLOWING: THE CORRECT SELECTION AND POSITIONING OF THE DEVICE IS EXTREMELY IMPORTANT. SUCCESS OF THE PROCEDURE REQUIRES THE SELECTION OF THE PROPER SIZE, SHAPE AND MODEL FRACTURE FIXATION APPLIANCES. THE FOLLOWING FACTORS ARE OF EXTREME IMPORTANCE TO THE EVENTUAL SUCCESS OF THE PROCEDURE. THE PATIENT¿S WEIGHT. AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE HIGHER LOADS ON THE DEVICE WHICH CAN LEAD TO FAILURE OF THE DEVICE. THE EFFECT OF THESE LOADS WILL BE ACCENTUATED WHEN A SMALL SIZED DEVICE MUST BE USED BECAUSE OF BONE SIZE. PATIENT¿S ACTIVITY. IF THE PATIENT¿S ACTIVITY COMPRISES SIGNIFICANT IMPACT LOADS (WALKING, RUNNING, LIFTING OR TURNING) THE RESULTING FORCES COULD LEAD TO FAILURE OF THE FIXATION, THE SYSTEM OR BOTH. THE SYSTEM WILL NOT RESTORE FUNCTION TO THE LEVEL EXPECTED WITH NORMAL HEALTHY BONE, AND THE PATIENT SHOULD NOT HAVE UNREALISTIC FUNCTIONAL EXPECTATIONS. (SEE PRECAUTIONS SECTION FOR MORE INFORMATION). [¿] IMPLANT SIZING. THE CORRECT-SIZED APPLIANCE FOR A GIVEN PATIENT SHOULD BE UTILIZED. THIS CAN BE DETERMINED BY EVALUATING THE PATIENT¿S HEIGHT, WEIGHT, FUNCTIONAL DEMANDS AND ANATOMY. THE APPLIANCE SHOULD BE USED IN THE CORRECT ANATOMIC LOCATION, CONSISTENT WITH ACCEPTED STANDARDS OF EXTERNAL FIXATION. ADVERSE EFFECTS IN MANY INSTANCES, ADVERSE RESULTS MAY BE CLINICALLY RELATED RATHER THAN DEVICE RELATED. THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NONUNIONS. EXTERNAL 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 FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING, AND THE PATIENT¿S ACTIVITY LEVEL, WILL DICTATE THE LONGEVITY OF THE APPLIANCE. CONDITIONS ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, OSTEOMALACIA, DIABETES, INHIBITED REVASCULARIZATION AND POOR BONE FORMATION CAN CAUSE: LOOSENING, BENDING, CRACKING, FRACTURE OF THE DEVICE OR PREMATURE LOSS OF FIXATION WITH THE BONE DELAYED UNION OR NONUNION OF THE FRACTURE SITE. IMPROPER ALIGNMENT CAN CAUSE A MALUNION AND/OR BENDING OR FRACTURE OF THE DEVICE. EARLY OR LATE INFECTION, BOTH DEEP OR SUPERFICIAL. DEEP VENOUS THROMBOSIS. AVASCULAR NECROSIS. SHORTENING OF THE AFFECTED BONE/FRACTURE SITE. SUBCLINICAL NERVE DAMAGE MAY POSSIBLY OCCUR AS A RESULT OF THE SURGICAL TRAUMA. METAL SENSITIVITY REACTIONS IN PATIENTS TREATED WITH EXTERNAL FIXATION DEVICES HAVE RARELY BEEN REPORTED, AND THEIR SIGNIFICANCE AWAITS FURTHER CLINICAL EVALUATION.¿ [ORIGINAL STATEMENT] NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    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

    TWO HA BLUNT APEX PINS ON A LRF FRAME BROKE & 1 BLUNT TIP HA PIN PULLED OUT OF PATIENT. PINS WERE REPLACED TODAY.

    Description of Event or Problem · 1

    TWO HA BLUNT APEX PINS ON A LRF FRAME BROKE & 1 BLUNT TIP HA PIN PULLED OUT OF PATIENT. PINS WERE REPLACED TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319202 BLUNT HALF-PIN APEX HA-COATED Ø 6MM, 200 X 30MM PIN, FIXATION, THREADED JDW STRYKER TRAUMA SELZACH F04534

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention