It was reported that intra-operatively, user seeded blade into handpiece, there was considerable vibration.User tried resetting the blade and locking the blade but the vibration was considerable.Procedure was completed with the another blade.There was delay of three minutes.There was no patient injury.
|
H3: medtronic evaluated that visually, there was contamination on the outside diameter of the outer tube.The inner shaft was marginally bent distal to the inner hub when returned.Functionally, the inner assembly spun freely by hand with no binding.For further analysis, the blade fit securely into a handpiece, but while oscillating at 1500rpm, the device had excessive wobbling.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint.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.
|