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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection revealed wear marks on the device; also, the device does not show any structural anomalies.Upon reviewing the upper jaw, it was found that was loose.When the trigger was fully depressed, the jaw cannot be closed completely.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the loose jaw can be attributed to procedural variables, such handling of the device or product interaction during procedure, a bigger portion of tissue may have been grabbed and forced the jaw to close, also, since this device is reusable, the continuous use and sterilization process can cause metal fatigue leading to a non-closing jaw, however, this cannot be conclusively determined.As per ifu, it is important to inspect the device prior to use to ensure proper mechanical function and do not use if product is damaged.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.
|
It was reported by sales rep that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the jaws on the expressew iii suture passer w/o hook device were not closing.During in-house engineering evaluation, it was determined that the upper jaw on the device was loose.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
|