Catalog Number 991016 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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Long rod that is used intraoperatively to make precise degrees of slope is slightly bent causing a skewed representation of the slope.
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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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Examination of the submitted device confirmed the reported bent condition.A search of the complaint database against product code (b)(4) did not identify any trends of device damage.The root cause is attributed to product wear out from repetitive leveraging of the rod during removal from the patient.Based on the determination of product wear out and user technique as the root cause and the low frequency of reported events, the need for corrective action is not indicated.Monitor complaints through (b)(4).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.
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Search Alerts/Recalls
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