If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint devices are not being returned, therefore are unavailable for a physical evaluation.A batch record 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 with an unrelated (non-conformance / out of tolerance) to the reported incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.Udi: (b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Associated medwatch: 1221934-2018-52274.
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It was reported by the sales rep that two of the customer's g11 quick anchor plus had sutures break while testing fixation of the anchor during an ankle procedure.He stated the first time it happened, the surgeon left the anchor in the bone and inserted a second anchor in another bone hole.He was testing fixation on the second anchor when the sutures also broke with the second one.The surgeon decided to remove both anchors, insert a third bone hole and inserted a new anchor from a different lot with no patient consequences or issues.There was a ten minute delay and both devices were discarded already by the customer.The bone quality was good.The sales rep was not present and does not have further information.
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