Method: the actual product involved with the incidents were discarded by the end user.No photos or samples were provided for review/testing.Results: no samples were returned for review.Relevant portions of the device history record could not be reviewed as the lot number reported does not match any lot in our system.Conclusion: without receiving the finished good lot number, samples to review/test, detailed information regarding the surgeon's technique, material placement in tissue, pre-operative preparation, and/or post-operative instructions or events a definitive root cause for the partial dehiscence cannot be determined with certainty.
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It was reported by the sales rep that the patient had a total hip procedure and the wound was closed with stratafix suture along the subcuticular layer of the skin.The patient returned, post-op, complaining about wound dehiscence along the skin closure.The doctor noticed the barbs of the suture weren't holding the tissue together and could be seen sliding back and forth after the suture was placed.The patient was treated with steristrips and released.Seven (7) cases reported.No patient specific information was provided.The exact date of event is unknown.
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