Model Number 2245-10-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/20/2021 |
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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Initial report: very sclerotic bone.Rep present and followed standard surgical technique.Instruments damaged upon use.Surgical delay 5 minutes.Procedure successfully completed.No consequence to patient.Further information provided; the awl was bent.The tip of the proximal reaming handle snapped off.The proximal reaming guide was damaged upon removal as was stuck in the patient after the proximal reaming handle snapped.Had to remove with mole wrench / pliers and roughed up the ends.
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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 device could not confirm the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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