It was reported by the affiliate via complaint submission tool that during an arthroscopy after putting both of the truespan 12 degree peek in the meniscus.The suture gets block and doesn't not allowed to tense them, this made a loop over the meniscus.The action taken was that the suture had to be pulled out.Case was able to be completed.No patient consequence and no surgical delayed was reported.It was later reported by the affiliate that the case was completed with a fast fix; which was readily available, and there were no known consequences.It also reported the product would not be returned for evaluation.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.No nonconformances were identified for this part-lot number combination.The complaint device is not being returned.It was implanted in the patient, and therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause could be an issue with the suture management tube resulted in laxity of the suture.However, without the return of the complaint device, and no further information provided, we cannot determine a definitive root cause for the reported problem.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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