One 72203378 healicoil pk 4.5mm device was used for treatment but was not returned for evaluation.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.Due to product unavailability, the complaint could not be ultimately confirmed.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device storage and transit.The allegation symptom is consistent with a storage/transit exposure issue.A visible condition such as this, would have been raised up during pre-release.As with any surgical instrument, careful attention should be made to assure that the product package is retained in a safe location and condition.This applies to transit and storage situation as well as during use.Final product met specifications upon release to distribution.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time no clinical signs, symptoms or conditions.No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.Health effect appears to have occurred but there is not yet enough information available to classify the clinical signs, symptoms and conditions.
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