Catalog Number UNK SAW BLADE |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 09/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 patient had left tka and the blade broke while cutting the posterior chamfer on the 4 in 1 block.Unable to find all of the broken pieces.Intraoperative x-ray was taken to confirm if the pieces were not retained.This caused approximately 15-20 minutes delay.
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Manufacturer Narrative
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Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Event Description
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Additional information was received stating that the tip of the blade broke.The broke blade pieces were never found as documented by the nurse.X-ray confirmed the pieces were not retained.
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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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Search Alerts/Recalls
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