It was reported that the patient swallowed the tool during a procedure, patient is okay, tool was found in his stomach.It is unknown if the tool was removed or not, patient feels well.
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Zimmer biomet complaint number (b)(4).The tool hex sst 1.25mm 17mm (hx1.25) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.The reported event could not be recreated due to the nature of the dental device and event (ingested device).Device history record (dhr) review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the hx1.25 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.
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