Model Number 2545-00-525 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 08/24/2020 |
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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One of the feet that mounts to the hole in the shims are broken off.Where / when did the event occur? postoperative.Was surgery time extended as a direct result of incident? no.What action was taken/required to manage the problem during the procedure? unknown.Was a patient involved? no.
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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 confirms damage to the device.A post of the instrument was broken, and a balseal was also found to be missing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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