Catalog Number 963204000 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2023 |
Event Type
malfunction
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Event Description
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Surgeon inserted hardinge cement restrictor into femoral canal size 3 c-stem has been prepared.Two of the hardinge fins snapped off inside the patient.Surgeon recovered the snapped pieces and continued the operation.
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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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Additional information was received and stated that there were no adverse events for the patient.The surgeon upon seeing the fins had to spend a couple of minutes picking them out of the femoral canal.Once complete, he continued with the operation as expected.
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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: a3, a4, b5, d4 (lot), h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3, g1.
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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 information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 manufacturing record evaluation (nc search) was performed for the finished device product code - 963204000, lot code - d23021156 and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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