MEDTRONIC SOFAMOR DANEK USA, INC POWEREASE¿ INSTRUMENTS; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
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Model Number 2342306M |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2022 |
Event Type
malfunction
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Event Description
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Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient implanted with old hardware in a revision fusion thoracolumbar with solera.It was reported that while removing the old hardware, the tip of the driver broke.There was no fragment of the driver remaining in the patient's body. there were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.The previously implanted products were no longer needed, there were no allegations against them, and they were not replaced during this event.No further complications were reported/ anticipated.
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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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H3: product analysis part #2342306m ; lot# ct20g050- visual and optical examination confirmed that approximately 2mm of instrument tip has been broken and the corners of the torx tip have been rounded off.The remaining tip has also been twisted.This type of damage is consistent with torsional overload.H6: updated eval.Code method and eval.Code result post analysis.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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