Model Number 2218-36-152 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/08/2023 |
Event Type
malfunction
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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.Visual examination of the part denoted a remarkable worn condition throughout the part.Several nicks were observed.No discoloration was observed on the device.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.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 that central sterile has brought to sales representative attention some instruments that are broken, and need replaced.These instruments were not involved in a surgery, they were noticed during assembly and inspection.The femoral trial has crack at notch, the pinnacle poly liner trials, one is discolored, the other has sharp edges around edge.Sales representative returning all for further inspection.No one was injured, no surgery involved.
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Search Alerts/Recalls
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