Model Number 2544-00-520 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/22/2021 |
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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Femoral alignment jig does not line up properly with the degrees on the dial.Surgery delay 5 minutes.Procedure successfully completed no patient consequences.
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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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Event Description
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Additional information received states that the numbers and arrows on guide are just off center.No broken pieces.
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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: added: d9: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
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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 investigation did not indicate that a broader investigation or corrective action was necessary at this time.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.Device history lot the receiving and inspection records were provided for review.Product code 254400520, lot number ab5042069 is comprised of 54 parts.All markings were verified to be legible complete, and correct.All criteria passed inspection.No non-conformances were identified.See attached records for further details.
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Search Alerts/Recalls
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