Model Number 2178-63-196 |
Device Problem
Connection Problem (2900)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
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Event Date 04/26/2018 |
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.
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Event Description
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It was reported that when passing the cemented reamer through the bushing it got stuck and would not continue reaming.Need new parts sent to (b)(6) warehouse.
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Manufacturer Narrative
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(b)(4).Investigation summary functional testing of the returned device confirmed the reported event.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Event has incorrectly been reported as serious injury.Correct report type is malfunction only.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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