The device intended for use in treatment was returned for evaluation, establishing a relationship between the event reported.The functional evaluation found did not reveal any malfunction.The visual evaluation found scratched and cracked casing.It is not possible to determine the exact cause.However, factors that are known to contribute to this type of issue, included mishandling, drop damage, improper storage and the use of harsh abrasives and cleaning products.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported¿event has been reviewed, revealing further instances, however no further action is deemed necessary.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.
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