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.Udi: (b)(4).The expiration date is not currently available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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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This is report 1 of 2 for the same event.It was reported by the sales rep that during meniscal repair surgical procedure, it was observed that the trigger of the truespan 12 degree peek did not deploy first implant all the way and then broke to where trigger could not be depressed the second time.The procedure has been completed without surgical delay.It was not reported if a spare device available or needed for use to complete the surgery.There were no fragments generated.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Product complaint # (b)(4).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.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.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [5l81951] number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Udi: (b)(4).The expiration date is unknown.
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