Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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It was reported by the customer in (b)(6) that during a knee arthroscopy with meniscal repair surgery on an unknown date, it was observed that the truespan 12 degree peek device jammed during release.According to the report, there was tear of the meniscus which was no longer suturable.It was further reported that the event could have led to a total tear of the meniscus and the resulting arthrosis with late consequences.The status of the patient postoperatively was unknown.No additional information was provided.
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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.H10 additional narrative: investigation summary : the device was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection, there were no anomalies or structural damage on the outside of the device.The stop tube was cut to verify the presence of the implants and they were missing.The red trigger was tested several times and it worked as intended.Manufacturing record evaluation was not required as the reported event was not associated with the manufacturing process and/or the potential cause of the defect could not be associated to manufacturing.Based on the condition of the device received, this complaint could not be confirmed.There were no details provided as to when this failure had occurred and no additional information was available; therefore, a definite root cause for this failure could not be determined.The possible root cause for the deployment failure could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the implant, and when this occurred may have felt resistance.As per ifu: it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue; once inside the joint space, remove the instrument.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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