Udi: (b)(4).A review of the lot records was conducted.A non-conformance was initiated to address a discrepancy between the revisions at which the product lot was ordered and manufactured.The evaluation determined that the product lot was manufactured to the current revision and that there was no impact to product quality.There were no indications that the non-conformance could have caused or contributed to the complaint.The part was not returned to integra for investigation, but x-ray images were provided.Evaluation of the provided x-ray images showed that the nail appeared to be fractured into two pieces.The failure was confirmed.As the implant has not yet been returned, a definitive root cause cannot be determined.According to a previous similar complaint, potential causes for the failure included premature and excessive loading of the implant.The panta2 instructions for use state that the panta implants ¿are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.Load bearing or weight bearing in the presence of a delayed union or non-union may eventually contribute to or cause implant breakage¿.If the part is later returned, this complaint may be reopened and further investigation conducted.
|