Catalog Number 254501040 |
Device Problems
Contamination /Decontamination Problem (2895); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).B3: date of event is an unknown date in 2023.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.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 reported that the attune patella cut guides have been in use for several years.It was noticed that the guides are difficult to clean because of saw marks on the clamp.No patient consequence or surgical delay reported.
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Manufacturer Narrative
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Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received.A.What is the date of event? -there is no specific date, as the account had noticed this as an ongoing issue and asked for replacements due to the patella cut guides having ceable saw notiblade damage.B.Please verify if the instrument was used during surgery? if yes, was there any surgical delay? what was the duration of the delay? -any contaminated instruments were not used during surgery, so there was no delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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Search Alerts/Recalls
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