Model Number 86-5226 |
Device Problem
Break (1069)
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Patient Problems
Not Applicable (3189); No Code Available (3191)
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Event Date 06/02/2020 |
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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Revision total knee; the stem trial extractor was broken whilst trying to remove the fluted rod trial.The tip broke & the stem trial had to be removed with other general surgical instruments.No pieces were left in the patient.No ae to patient.7 minute delay to the procedure.
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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.The noted damage is consistent with improper user technique through excessive leveraging/torquing of the device and the investigation did not establish a need for corrective action.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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Event Description
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Additional information received stated that the piece that broke off the stem extractor remained in the fluted stem trial.The stem trial connection to the drill wasn¿t as snug as a new instrument.
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Manufacturer Narrative
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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).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: corrected h3.Added d10.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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