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 school of medicine, (b)(6).The title of this report is ¿carpal tunnel release using a short palmar incision and a new knife¿ which was published in august 2000 and is associated with the stryker knifelight.Within that publication, intraoperative/post-operative complications/ adverse events were reported.It was not possible to ascertain specific device 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, 5 complaints were initiated retrospectively for different adverse events mentioned in the study.This product inquiry addresses knifelight breakage intraoperatively.The study states: ¿in one patient, in the earlier part of the study, the preliminary 3 to 4 mm scalpel incision in the flexor retinaculum was not performed: the increased force required to cut the retinaculum broke the long skid of the knife, which was retrieved easily.¿.
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