(b)(4).Due to the intra-operative events, the implant was not successfully implanted.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017 after cutting the zipfix with the application instrument, the locking head of the implant opened again.The implant was removed.The sales rep tested the zipfix and the locking head seemed to work.The surgery was not prolonged.Instead of five only four zipfix were implanted; however the surgery was successfully completed.No information available about patient condition.Concomitant reported devices: application instrument (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).
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