This is a new request for correction of an initial mdr report to match with the correct follow-up report # 25231902015-00103.Integra has completed their internal investigation on 10/06/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; one of the wires slightly came out of the tube.The bipolar connectors are bent.However, the risk for the patient or the user is very low since the insert cannot be used in this condition.The coating on the distal part of both wires is damaged.Dhr review; no nonconformity related to this issue for this lot.Complaints history; no complaint for this lot.Conclusion: the connectors probably got bent because of a mishandling during the assembly of the insert on a handle.This led to the ungluing of the wire and to its displacement.The damages on the coating are in all likelihood due to the use of an abrasive to clean the active part.
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