Model Number 2001-48-000 |
Device Problems
Failure to Cut (2587); Contamination /Decontamination Problem (2895); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the edges of the medium size calcar have begun to bend and an issue for sterilization, because bone gets lodge into this crease and is difficult to remove.Surgeon has noticed that the planar's have become duller and not cutting as efficiently.
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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.H10 additional narrative: added: a1, a3, d4 (lot), d9 and h4 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 = > the device associated with this report was received for investigation.Visual examination of the returned instrument confirmed the dullness complaint.Cutting surface, thus a normal wear by usage, is not as sharp as first use condition.Also there was possible to observe rounded edges on the mill's dentition.There was not possible to identify a debris or a substance on the device after sterilization process.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.
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Search Alerts/Recalls
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