Catalog Number 221750001 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2019 |
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 the instrument was found broken in tray.No surgical delay.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.The root cause is attributed to inadvertent use error.A design change was implemented in july of 2019 to help alleviate this type of complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.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).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.Added: description of event or problem, concomitant medical products and evaluation codes.Corrected: device evaluated by mfr.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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Additional information received indicating that it is unsure how the instrument got broken since they found it in the tray that way.Instrument had the one broken piece missing.He found the instrument already broken in the tray the teeth of part of the instrument.The piece broken off was not in the tray either.
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Search Alerts/Recalls
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