Model Number TPL0059 |
Device Problems
Imprecision (1307); Mechanical Problem (1384)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/11/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Other relevant device(s) are: product id: asm0206.A medtronic representative went to the site to test the equipment.Testing revealed that the surgical arm was replaced.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that when setting up for the case they performed a 3define and then draw spine.The draw spine was up in the air and not on the patient.The surgeon continued on anyway.They sent the arm to the first trajectory and it was on the bone but not completely lined up.The surgeon continued on and placed the screw.They sent the arm to the second location and it was off the bone completely.They resent the arm and it was closer but still a little off.They placed the screw.They then went to the right side trajectories and they were off.They then re-registered with a snapshot.The third screw was then able to be placed.However, the fourth was still way off.They took another snapshot and it was still way off so they aborted and did the last screw by hand.The arm also failed the stress test.The issues extended the surgical time by less than 1 hour.There was no impact on the patient outcome.
|
|
Manufacturer Narrative
|
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.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.
|
|
Event Description
|
Additional information was received stating that the screws were off by 3.5 mm or less.
|
|
Manufacturer Narrative
|
H3: analysis of the surgical arm found the complaint was confirmed.Visual/physical examination and functional testing found the j2 plastic cover was broken, the j1 usb cover was broken, the j2 encoder failed, the j2 bearing failed, the emergency stop wires were broken/torn, and the camera was the old version.The surgical arm was repaired, recalibrated and passed all testing.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.
|
|
Search Alerts/Recalls
|
|