Model Number 2545-00-138 |
Device Problems
Break (1069); Device-Device Incompatibility (2919)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that attune rp insert trial extractor forks broke off during use.This was a persisting issue with this instrument.There was a 10 minute surgical delay.
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.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).A manufacturing records evaluation (mre) was not performed.
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Event Description
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Additional information received stated that the broken instrument and the statement that it is a persistent issue stems from the years since the intuition instrument launch the tips of the instrument have the propensity to break off if used incorrectly.There was a time added to the case because it was difficult to remove the insert trial.Most likely due to the selected insert trial being too thick.
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Search Alerts/Recalls
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