Model Number 2024-40-100 |
Device Problems
Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2020 |
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 during the case while using the sigma uni tibia cutting block, the threaded headed pin became stuck inside the cutting block.The surgery time was not extended because the surgeon could still make his cut using the tibia cutting block.
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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 confirmed the reported event.A fixation pin was stuck in one of the pin holes of the cutting block.Furthermore, the head of the shaft was broken.The need for corrective action is not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H6 (component code): part/component/sub-assembly term not applicable (g07001) is being utilized to capture mechanical jam (a0506).
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Search Alerts/Recalls
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