SYNTHES GMBH CRESCENTIC BLADE 15MM RADIUS/45MMX0.6MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 03.000.391 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2022 |
Event Type
malfunction
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Event Description
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It was reported from italy that during a veterinary surgical procedure of the knee for a dog it was observed that the saw blade device did not cut at first use.It was observed that the blade was not sharp.It was reported that a new blade was used, and the procedure was successfully completed.It was not reported if there was a delay in the procedure due to the event.There was no human patient involvement as this was a veterinary procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi - (b)(4).
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: this device was returned for evaluation.A visual and functional assessment was performed which determined that the device passed all pre-repair diagnostic assessments, and no failures were identified.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.A review of the device history was performed and no non-conformances were detected related to the reported condition.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Correction h4: the device manufacture date was reported as october 5, 2021 in the initial medwatch report.This has been updated to march 9, 2021.
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