Catalog Number 221750008 |
Device Problems
Scratched Material (3020); Illegible Information (4050)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 09/30/2020 |
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 the orange 36 mm impaction tip and the 32x50 liner trial are scratched.Also the reference and lot numbers of both instrument have worn off, making them hard to read.Both are in one piece and were retrieved from the patient.This did not delay surgery time.
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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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
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Search Alerts/Recalls
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