Catalog Number 961673 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/19/2017 |
Event Type
malfunction
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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.Udi: (b)(4).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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Screw is missing from the handle of the torque wrench.
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Manufacturer Narrative
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Examination of the returned device confirmed the missing screw.The missing screw was not returned.A worldwide complaint database search for the product 961673 did not identify a trend of missing screws.The root cause of the missing screw is unknown.No conclusions could be drawn without the screw to examine.Based on the inability to determine a root cause, a need for corrective action is not indicated.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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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.(b)(4).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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Search Alerts/Recalls
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