It was reported that during service and repair evaluation, it was determined that the vapr vue wireless footswitch device was not pairing and had a broken insert.During in-house engineering evaluation, it was determined that the device had broken inserts on the housing.There was no procedure nor patient involvement reported.No additional information was provided.
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Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that no pairing and broken insert.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: low batteries.Broken inserts on the housing of the unit.Minor scratches on the unit.The repair of the device was however declined, and it is being placed on long-term hold.The faulty parts were identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated with manufacturing.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field.
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