The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned.Typically, anchor pull outs are associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.It is a possibility that any of the aforementioned factors or a combination of factors could have possibly lead to this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any 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 for this lot of devices that were released to distribution.From the complaint history, it seems that this failure is an anomaly and an isolated incident.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.
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