The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device evaluated by mfr: device disposition is unknown.
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The manufacturer became aware of a study from the department of (b)(6) infirmary, (b)(6).The title of this report is ¿evaluation of carpal tunnel release using the knifelight instrument¿ which was published in june 2003 and is associated with the stryker knifelight.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the article; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 22 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses mild scar tenderness.4 out of 15 cases.
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