Catalog Number 536318 |
Device Problems
Bent (1059); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/02/2018 |
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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New rep at (b)(6) medical center.Went through instrument inventory on (b)(6) 2018, and noticed a few instruments that were in an unacceptable condition.This instrument was not used during a surgery and no staff member had mentioned the damage.This is a srom 18 proximal body (color: green).The grooves where the neck trial sits are damaged (bent, chipped).Asking that these are replaced and shipped to: (b)(6).The damaged instrument will be returned to (b)(4).Lot code: ah0604.On the complaint tool; you are unable to add the lot code.The product won't add/upload when the lot is also typed.Patient consequence? no.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned instrument confirmed the complaint.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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Search Alerts/Recalls
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