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 (b)(6) university education and research hospital, (b)(6).The title of this report is ¿comparative results of standard open and mini open, knifelight instrument-assisted carpal tunnel release¿ which was published in august 2013 and is associated with the stryker knifelight.Within that publication, post-operative complications/ adverse events were reported, which occurred between january 2009 to november 2011.It was not possible to ascertain specific device information from the study; 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, 2 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses transient numbness.The study states that ¿and one had transient numbness of the index finger.[¿] after 6 months, none of the patients needed re-operation in this group.¿.
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