This file is a review of the following journal article: park, s., et al (2014) arthroscopic management of occult greater tuberosity fracture of the shoulder, vol.24, pages 475-482.(south korea).The study emphasizes on the evaluation of the early results of arthroscopic treatment in patients with missed occult greater tuberosity (gt) fracture of the humerus using the arthroscopic suture¿bridge fixation technique.The patients evaluated on course of this study: there were 13 male and 2 female patients with a mean age of 45 years (range 31¿67 years).The article describes the following procedure: rotator cuff repair.The devices involved were: versalock anchor.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = this complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Additional information was requested, however no further information has been made available.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.Given that no lot number was provided, a manufacturing record evaluation (mre) or sterile load review cannot be performed.If the lot number becomes available, the mre review will be performed.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 with which this complaint is observed in the field.
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