Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed one similar and one dissimilar complaint for this lot of devices.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.(b)(4).
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It was reported by the sales rep via phone that during a shoulder/ rotator cuff repair procedure the tip of the customer's expressew iii needle broke off in the patient's joint.The surgeon search for about 5 minutes for the broken tip and could not find it.The surgeon stated to the rep that the tip most likely got flushed out.No x-rays performed, the needle broke during the second pass, and an expressew iii gun with orthocord suture was used with the needle.The procedure was completed by using the same gun and another needle.There was no harm to the patient but there was a five minute delay due to searching for the broken tip.The sales rep stated that the device was discarded.
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