Catalog Number 257002200 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976)
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Patient Problem
Not Applicable (3189)
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Event Date 04/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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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During a total hip arthroplasty, the surgeon was reaming the femoral canal with a summit 4/5 reamer and found that the reamer continued to disconnect from the t-handle attachment.There looks to be damage at the connecting end of the reamer (damage looks like dents/dings to the connecting end, confirming why it would disconnect from t-handle).To confirm that it was the reamer and not the t-handle, the surgeon tested the other reamers on the t-handle and they worked fine.He then tested the reamer on the hudson power attachment and it would disconnect from the power attachment - confirming that the summit reamer was indeed the issue.There was approximately a 1-2 minute delay.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Examination of the returned instrument confirmed the reported observation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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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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Search Alerts/Recalls
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