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).D4: the expiration date is currently unavailable.E3: 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.Visual inspection revealed wear marks on the device, as usual in this type of reusable devices, the needle was found stuck into the shaft of the device, the needle tip was broken near the lower jaw.Finally, the jaws do not show structural anomalies.Based on the condition of the needle, a functional test cannot be performed.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 needle stuck can be attributed to when deploying the needle with the jaws open which can lead to a jammed needle.Another possible root can be attributed to an improper maintenance of the device that would lead to bio-debris build up inside the expressew shaft causing deployment issues.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.Also, it is necessary to follow the instructions to cleaning and sterilization process and between uses, lubricate moving parts with the water-solubel lubricant.Applying too much force when grasping tissue will impede passage of the needle and suture.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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It was reported by sales rep that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that a expressew iii suture passer w/o hook device had an unspecified malfunction.During in-house engineering evaluation, it was determined that a tip of a needle was found stuck inside its shaft near the lower jaw.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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