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Catalog Number 03.503.286 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2022 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, the drill bit were dull and the reduction was lost and the bone was refracted.The wires arrived cut and were too thin for the jaw, they had to use institution wire.This report is for one (1) drill bit ø1.1 w/stop l44.5/6.This is report 5 of 8 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: part 03.503.286, lot u326056: release to warehouse date(s): march 11, 2019 and august 02, 2019.Manufacturing location:(b)(4) final inspection and packaging by: monument.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.A product investigation was completed: visual analysis of the returned sample revealed that the drill bit was found to have nicks, also, the blade edges appear to be deformed.Functional issues are most likely due to this condition.The drawings reflecting the current and manufactured revisions were reviewed.A dimensional inspection for the drill bit was unable to be performed due to post manufacturing damage.A functional test was not performed since device functionality cannot be evaluated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the drill bit would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was noted the procedure being performed maxillofacial surgery.The procedure was completed successfully.The patient condition was reported as stable.
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Search Alerts/Recalls
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