Catalog Number 865226 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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During the case one of the extractors was bent and another was not functioning.**update (b)(6) 2016** follow-up with the sales rep indicates the distal shaft was all bent and the threads were damaged.
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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 threaded tip and shaft are bent.The root cause is attributed to misuse.The extractor was levered side to side which resulted in the bent tip conditions.Based on the root cause determination of misuse, the need for corrective action is not indicated.Continue to monitor complaints through sep-419.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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