It was reported by the affiliate in (b)(6) that during a meniscal repair procedure on (b)(6) 2021, it was observed that the shaft on the truespan 24 degree plga device became deformed due to the limited lesion space.The surgeon managed to fire the first implant though the trigger became tight.However, he was not able to deploy the second one.The 1st implant was removed, and another like device was used to complete the procedure.No fragment was left in the patient¿s body.There was no surgical delay and adverse patient consequences.No additional information was provided.The device was brand new and the first use when the issue occurred.
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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 complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (7l96065), and no non-conformance was identified.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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