Model Number 2360-71-000 |
Device Problems
Material Deformation (2976); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2022 |
Event Type
malfunction
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Event Description
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Impactor handle threads were damaged while impacting acetabular cup, right hip.No surgical delay or extended surgical time.No surgical delay.No adverse affects on the patient.
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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).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.Indicated, that the threads on the impactor were bent and stripped.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Visual inspection of the returned device found the threaded tip of the instrument is stripped and the handle impaction area was deformed.The reported condition was confirmed.Additionally, the white handle of the device was found cracked.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: a date code was provided, which indicates that the device was manufactured on (12/2005).A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.
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Search Alerts/Recalls
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