A review of the device history records for the finished good lots including sterility records, did not identify any quality issues during the manufacturing, in-process or final inspection processes.There are no other complaints reported for the lot.To date the samples have not been received by surgical specialties corporation for root cause and failure analysis.There were no retained samples available for review.Without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, results of the culture or blood screen to identify the type of infection/reaction and antibiotics prescribed, a definitive root cause cannot be determined at this time.Spitting of suture material can also be the result of placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.
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A review of the device history records for the finished goods and the raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.No other complaints were received for this finished good lot.The sterilization certificate for this particular lot was reviewed in detail and the method and all results meet the required guidelines.Two (2) sterile samples from lot: aadl188, and ten samples (10) from lot: aadk963 were received for visual and functional testing.No defects where observed.The devices met the current specification for a 2-0 pga-pcl device including the usp tensile strength requirements.The ¿adverse reactions¿ section in the ifu for the stratafix¿ spiral pga-pcl devices state, ¿adverse effects associated with the use of this device may include, wound dehiscence, failure to proide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site.¿ wound healing, irritation, infection are common risks/complications of any surgical procedure.There are many causes that can result in the wound or surrounding tissue becoming irritated, inflamed or infected following a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.Spitting of suture material can result from placing the material too superficially.The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event.Without receiving photographs of the incision/extruding suture or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, patient¿s pre-existing health conditions/allergies, placement of the suture material within the tissue, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, results of the culture or blood screen to identify the type of infection/reaction and antibiotics prescribed, a definitive root cause cannot be determined at this time.
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