Catalog Number 961673 |
Device Problem
Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2016 |
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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Upon inspection of the instrument, it was noticed the plastic tip is missing.
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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.
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Manufacturer Narrative
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Examination of the returned device confirmed the black plastic protector component was missing.The root cause is attributed to product design.(b)(4) has been initiated to remove the radel® socket cap altogether and replace with a teflon® (ptfe ¿ polytetrafluoroethylene) split ring and a peek (polyetheretherketone) disc to the torque wrench.The current complaint sample product was manufactured prior to the implementation of (b)(4).No further corrective action required.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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