Catalog Number 950501230 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 05/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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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The screw on the top of tibial jig did not work at all during the operation.As the jig could not be fixed, the alignment and setup of backward slope were not successful.Another device was used to deal with this problem.There was no adverse consequence to the patient.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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Additional narrative: examination of the submitted device confirmed the locking knob is frozen and will not rotate.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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