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| Device Problem
Vibration (1674)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/06/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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There were 8 surgeries performed on (b)(6) 2020 where the surgeon noticed the burs to be wobbly.The specific drill and bur used in each of the 8 surgeries is unknown.Hence, we are submitting mdr per surgery, and including all drills and burs used that day on each mdr.List of handpieces: part #/ description/ lot or serial #/ udi/ mfg date/ 510k info -3055601 / drill 3055601 skeeter oto-tool / 4262 / (b)(4) / ni / k833874 -3055601 / drill 3055601 skeeter oto-tool / sk-9359 / (b)(4) / 5-24-2016 / k833874 -3055601 / drill 3055601 skeeter oto-tool / 5744 / (b)(4) / ni / k833874 -3055601 / drill 3055601fce skeeter oto-tool--fce / 6357/ (b)(4) / 2-13-2008/ k833874 -3055601 / drill 3055601 skeeter oto-tool / sk-u10350 / (b)(4) / 1-16-2019 / k833874 -3055601 / drill 3055601 skeeter oto-tool / 9292 / asku / ni / k833874 -3055601 / drill 3055601fce skeeter oto-tool--fce / 6490/ (b)(4)/ 7-16-2008 / k833874 list of burs: all the burs listed below are 510k exempt.Part #/ description/ lot or serial #/ udi/ mfg date/ exp date -3155637 / bur 3155637 oto-flex.7mm carbide green / 0220076449 / 00681490070492 / 5-19-2020 / 5-17-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0220076449 / (b)(4) / 5-19-2020 / 5-17-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0220076447/ (b)(4) / 5-19-2020 / 5-17-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219854403/ (b)(4) / 4-06-2020 / 4-04-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219522877/ (b)(4) / 2-17-2020 / 2-15-2028 -3155637 / bur 3155637 oto-flex.7mm carbide green / 0219854403/ (b)(4) / 4-06-2020 / 4-04-2028.H10: this is same event as regulatory report #:1045254-2020-00526, 1045254-2020-00527, 1045254-2020-00528 and 1045254-2020-00529.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare professional (hcp) reported via manufacturer representative that they were having issue with the bur tips being wobbly and oscillating on the handpiece during the ear surgery procedure.They have 8 drills and the issue has been happening with all the drills and bur lots.They changed burs and all the burs were wobbly.The majority of the cases were stapedectomies.The facility informed us that they opened multiple bur packages in a single case to find one that wobbles the least.There was wobbling visible on the handpiece during the verification step, when the surgeon checks the rotation before inserting it in the patients¿ ears.The surgeon decided to use the burs even though it was wobbling.There was a delay of 10 or so minutes in a 45 minute case.There was no back-up device used.There was no patient impact.
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Event Description
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Additional information received that the reported burs that wobbled were initial use, not reprocessed, and some wobbled right out of the package.The bur was locked into place correctly.Hcp was familiar with the handpieces as he had used them for over 15 years.He performed troubleshooting by using the burs in different handpieces, to see the result.Each of the burs wobbled in a second handpiece; however, it was found that there was variability on how much of a wobble was evident with each handpiece (either more wobble, or less).The drills have recently been swapped out for new ones.The facility determined that this was an issue with their handpieces and returned each of their devices.Since the new devices have been in use, there has been no evident/reported wobble.
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Manufacturer Narrative
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H3: analysis results were not available as of the date of this report. a follow-up report will be submitted when analysis is complete.H6: additional information suggest that fdm:4114, fdr:3221 and fdc:67 no longer apply to this event.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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Manufacturer Narrative
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H3: there were 11 burs returned for analysis which are lot #'s 0220076449 (2), 0219522877 (6), 0220076447 (1) and 0219854403 (2).All burs were analyzed and the results are the following.And because we are not certain which bur was used to which surgery, we are including the analysis results of all burs in each report.Lot number 0220076449-2 opened samples.Analysis found that visually, there was no damage to the opened bur, which would have resulted in the reported malfunction.The xpi states, ¿bur assembly shall lock into skeeter handpiece at 700 rpm using oto-tool console indicator without noticeable wobble, visually 100%¿.The returned sample was placed into the handpiece and ran at 1000 rpm [the ipc minimum rpm is 1000]; there was no ¿noticeable¿ wobble with an unaided eye.When viewed under magnification, there was no visible damage to the green teflon bushing/sleeve.The bur run at 16,000 rpm and cut saw bone with no issues.There is no geometric dimensioning and tolerancing on the applicable drawings that control the reported wobble [i.E., runout, concentricity, true-position].Lot number 0219522877-6 opened samples.Analysis found that the xpi states, ¿bur assembly shall lock into skeeter handpiece at 700 rpm using oto-tool console indicator without noticeable wobble, visually 100%¿.The returned samples were placed into the handpiece and ran at 1000 rpm [the ipc minimum rpm is 1000]; 2 out 6 samples had a ¿noticeable¿ wobble with an unaided eye.There is no geometric dimensioning and tolerancing on the applicable drawings that control the reported wobble [i.E., runout, concentricity, true-position].When viewed under magnification, there was no visible damage to the green teflon bushing/sleeve.A concentricity gauge placed onto diameter 0.045¿ (sleeve location) and a dial indicator set at 0.210¿ from the proximal end of the bur tip measured an approximate run-out of 0.0045¿ for sample 1 and 0.0041¿ for sample 2, meaning the bur tips are eccentric to the bur blank shafts.Lot number 0220076447-1 opened sample.H3: analysis found that visually, there was no damage to the opened bur, which would have resulted in the reported malfunction.The xpi states, ¿bur assembly shall lock into skeeter handpiece at 700 rpm using oto-tool console indicator without noticeable wobble, visually 100%¿.The returned sample was placed into the handpiece and ran at 1000 rpm [the ipc minimum rpm is 1000]; there was no ¿noticeable¿ wobble with an unaided eye.When viewed under magnification, there was no visible damage to the green teflon bushing/sleeve.The bur run at 16,000 rpm and cut saw bone with no issues.There is no geometric dimensioning and tolerancing on the applicable drawings that control the reported wobble [i.E., runout, concentricity, true-position].Lot number 0219854403- 2 opened samples.Analysis found that visually, there was no damage to the opened bur, which would have resulted in the reported malfunction.The xpi states, ¿bur assembly shall lock into skeeter handpiece at 700 rpm using oto-tool console indicator without noticeable wobble, visually 100%¿.The returned sample was placed into the handpiece and ran at 1000 rpm [the ipc minimum rpm is 1000]; there was no ¿noticeable¿ wobble with an unaided eye.When viewed under magnification, there was no visible damage to the green teflon bushing/sleeve.The bur run at 16,000 rpm and cut saw bone with no issues.There is no geometric dimensioning and tolerancing on the applicable drawings that control the reported wobble [i.E., runout, concentricity, true-position].H6: the fdm-b01, fdr-c19 and fdc-d14 are codes applicable for lot numbers 0220076449, 0220076447 and 0219854403 while fdm-b01, fdr-c070605 and fdc-d03 are applicable for lot number 0219522877.Additional information suggest that fdm:b21, fdr:c21 and fdc:d16 no longer apply to all lot numbers.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.
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Manufacturer Narrative
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D1: additional information suggests that: s/n (b)(6) sn (b)(6) and s/n (b)(6) unknown mfg date s/n (b)(6) mfg date of 2-13-2008 no longer apply to this event.The product information below is the updated product details.Part #/ description/ lot or serial #/ udi/ mfg date/ 510k info -3055601 / drill 3055601 skeeter oto-tool / (b)(6) / (b)(4) / 4-20-2001 / k833874 -3055601 / drill 3055601 skeeter oto-tool / (b)(6) / (b)(4) / 8-3-2006 / k833874 -3055601 / drill 3055601fce skeeter oto-tool--fce / (b)(6) / (b)(4) / 2-14-2008/ k833874 -3055601 / drill 3055601 skeeter oto-tool / (b)(6) / (b)(4) / 10-29-2015 / k833874 h3: there were 7 handpieces involved in the event and 6 handpieces were returned for analysis which are sn #'s (b)(6) , (b)(6) , (b)(6) , (b)(6) , (b)(6) 92 and (b)(6).The returned handpieces were analyzed and the results are found below.Because we are not certain which handpiece was used to which surgery, we are including the analysis results of all returned handpieces in each report.Sn: (b)(6)analysis found that the handpiece was running rough due to burr loose.The unit was repaired, cleaned, tested and passed to manufacturing specifications.Sn:(b)(6) analysis found that the customer complaint could not be verified.There was no fault found with the unit.The unit was cleaned, tested and passed to manufacturing specifications.Sn:(b)(6) analysis found that the unit came in not working properly.The motors were intermitting and the nose bearing assembly is corroded.The motor on that units and nose bearing assembly need to be change.They are still waiting for motor parts.Sn:(b)(6) analysis found that the unit came in not working properly.The motors were intermitting and the nose bearing assembly is corroded.The motor on that units and nose bearing assembly need to be change.They are still waiting for motor parts.Sn:(b)(6) analysis found that the handpiece was not working.The motor was not running.Replaced the motor, the nose bur lock assembly and resolder the cable connector.The unit was repaired, tested and passed all manufacturing specifications.Sn: (b)(6) analysis found that the customer complaint was verified.The unit was not holding the blade properly and wobbling.The motor was not working properly.Replaced the nose tip and motor.The unit was repaired, tested and passed all manufacturing specifications.H3: additional information suggest that fdm:4114 and fdr:3221 no longer apply for serial numbers: (b)(6).While, fdc:67 no longer apply for serial numbers: (b)(6).Fdm-b01 applies to serial numbers:(b)(6).Fdr-c07 applies for serial numbers: (b)(6) while fdr-c09 apply for serial number (b)(6).Fdc-d02 applies for serial numbers (b)(6) while fdc-d1102 applies to (b)(6).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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