(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.The following information was requested, but unavailable: did the event occur during one or multiple patient/procedures? ¿ what is the total number of procedures? ¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).¿ if this event occurred in multiple procedures, please provide the following information for each patient/event: - procedure name and date? - quantity involved in each procedure? - quantity involved in each procedure? how many for lot rabcex and how many for lot rabdes? - event description stating when each involved device had a "incidence of the wire fracturing at the junction of the ¿needle¿ and wire" in the procedure.- please clarify if the suture broke into separate pieces or if the entire suture separated from the needle.- were there any adverse patient consequences? we attempted to get the answers to your questions, however we were unable to get this information.Please provide an investigation with the information you have been provided.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Note: events reported via: 2210968-2021-09393, 2210968-2021-09394, 2210968-2021-09395, 2210968-2021-09396, 2210968-2021-09398, 2210968-2021-09399, 2210968-2021-09400, and 2210968-2021-09401.
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