Catalog Number 244000510 |
Device Problems
Material Discolored (1170); Contamination /Decontamination Problem (2895)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint : (b)(4).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 this style of pinnacle grater handle does not detach at the top to get cleaned properly.Tissue and debris is getting stuck in them making them contaminated.We are requesting them to get replaced with the grater handles that can be taken apart at the top.No surgical delay.
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Manufacturer Narrative
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Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report. .
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Manufacturer Narrative
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Product complaint(b)(4).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. .
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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.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation and found some discoloration.The root cause is attributed to misuse and heavy usage.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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