Model Number 2178-63-136 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 10/22/2020 |
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 when the surgeon went to ream the canal, the mbt reamer adapter for the hudson from the mbt reamer tray.This added about 2 minutes to surgery time, it occurred with the final reamer and it was fixable in a sense that the surgeon managed.The top where the reamer attaches was stripped.
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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: d4 (lot #), d10 and h4.Corrected: h3.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 submitted device revealed damage.The investigation attributed the root cause of the event to device damage/wear from normal use and servicing and the need for corrective action was not indicated.Depuy synthes considers the investigation closed.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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