Model Number 2545-00-119 |
Device Problems
Device-Device Incompatibility (2919); Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2022 |
Event Type
malfunction
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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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Event Description
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It was reported by nursing staff the short pins from attune consignment tray are damaged and no longer stay in the pin driver.No surgical delay.No adverse affects on the patient.
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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.
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Manufacturer Narrative
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Product complaint #(b)(4).Investigation summary: the device associated with this report was returned for analysis.Review of the photographic evidence and visual examination of the device confirmed the complaint.Attune base pins (product code: 254500119) presents scratches and nicks on the shaft.Additionally, the attune base pin shaft is bent, although the involved mating device was not returned for a functional test, it is not unreasonable to conclude that the observed condition of the device prevents from proper assembly.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: a manufacturing records evaluation (mre) was not performed as no lot number was retrieved for this device.
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Search Alerts/Recalls
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