H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the tooth of the blade safety was broken, the piece was not returned.There was evidence of use on the device.It was reported that the cutting function of the product did not work and the tooth of the blade safety was broken.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: to divide tissue, maintain steady pressure on the ring handles and pull the cutting trigger until a hard stop is reached.Then release the cutting trigger to allow the cutting blade to retract.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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According to the reporter, during a procedure, the cutting function of the product did not work and the tooth of the blade safety was broken.The surgery was completed with a new product.Nothing fell on the patient's cavity.There was no patient injury.Medtronic's initial evaluation of the incident device found the tooth of the blade safety was broken, the piece was not returned.
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