If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported by the affiliate in (b)(6) that intra-operatively the tornado shaver hand piece did not sniff.User was involved but the outcome of the user is unknown.The case was completed by using another device.The outcome of the event and patient are unknown.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the device was received at service center and evaluated.The complaint is not confirmed.The defects reported by the customer have been verified and repaired.On inspecting the device, further deficiencies were found to be impairing device function.The measures used for repairing the defects as per the service report."tornado": preventive replacement of o-rings performed.Motor does not turn: motor replaced.Protective conductor resistance out of tolerance - motor cable replaced.Defective o-rings replaced.Unit cleaned.Functional test performed.Functional test completed.Safety test checklist enclosed.Electrical safety test completed.Hipot test completed.Since the reported condition is not confirmed the root cause for the reported failure in undetermined.This device was produced prior to the closure of the fms facility in nice, france and therefore will not have a dhr review preformed.At this point, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
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