Udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek's product failure(s).It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
|
It was reported by a healthcare professional through a review of a clinical research report for clinical evidence on safety and performance of 5.5mm healx adv sp peek anchor device that postoperatively to a rotator cuff repair procedure performed on an unknown date in 2020, a patient had a revision 49 days after the initial procedure that included irrigation, debridement, and removal of hardware due to postoperative infection in the right shoulder.According to the report, the patient had the infection 38 days after the initial procedure.The current status of the patient was unknown.No additional information was provided.
|