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Model Number 1882569HS |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/03/2022 |
Event Type
malfunction
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Event Description
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Hcp reported that during intra-op stage, the blade broke and a piece of the bit fell in the patient.The piece was recovered from the patient.Additional info.On follow up.There was a malfunction with the handpiece as the drill dcr bur got jammed in the collet of the handpiece and is still currently in the handpiece.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information received right ethmoidectomy with dacryocystorhinostomy procedure being performed.When the piece broke off in the patients nasal cavity it was retrieved with another ent instrument call a takahashi.The speed being used at time of incident was 12000.The dcr bur was being used in the forward motion.
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Manufacturer Narrative
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Product analysis found that the visually, the inner shaft broke approximately 1.33 inches from the distal end of the inner hub.The outer tube also broke near the distal end of the outer hub.There were portions of the inner shaft missing including the distal tip.The proximal end of the outer hub was lodged inside the handpiece collet.There was deformation in the distal outside diameter of the inner hub which would have resulted in the reported event.The outside diameter of the inner hub should be 0.330 ± 0.002 inches and measured 0.330 inches in the undamaged area and up to 0.352 inches in the deformed area which was out of specification.The inner hub bushing was dislodged and missing from the assembly.The outer hub bushing was rough and worn.The inner hub seal was in place but was worn.The inner shaft showed extensive wear.Functional testing could not be performed due to the broken state of the device.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 (due to physical damage).Previous codes b17, c20, d14 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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