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), incomplete.The expiration date is not currently available.Investigation summary: the complaint device was not returned and it was discarded by the customer, therefore unavailable for a physical evaluation.We cannot discern a root cause for the reported failure mode.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
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It was reported from (b)(6) that during a meniscectomy surgical procedure, it was observed that when the surgeon introduced the truespan peek device into the knee joint and tried to insert the needle to the meniscus, the needle tip hit the bone and bent.Since the needle tip was bent, the device in question was not used.Other competitive product was used to complete that meniscus suturing.It was reported that the device was brand new and its first use when the issue occurred.There was a 10-minute-delay in surgery and no harm to the patient.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.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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