Three opened trocar handle/blade assemblies, 1 opened trocar hub/cannula assembly, 2 opened hubs, and 2 opened cannulas were received for the report of trocar came apart and came out of incision.The returned hub/cannula samples were visually inspected.The trocar hub/cannula assembly (sample 1) was found to be conforming.The hubs and cannulas that were received separated (samples 2 and 3) were found to be non-conforming.The hubs returned with the cannulas separated had a presence of adhesive inside of the hubs.A functional push out test was performed on sample 1 and was found to be conforming.Photos attached to the parent complaint were reviewed by the manufacturing site.Photo 1 confirms the reported product and lot numbers photo 2 shows 2 separated trocar hub/cannulas.The hubs were separated from the cannulas.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned samples identified adhesive inside of the hubs, therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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