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Model Number UL-3023-S |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The returned 3.0mm ulna nail, im rod targeting base, and im rod locking bolt were visually and functionally examined.The three products were returned together in a single assembly.The locking bolt was able to disengage from the ulna nail when un-screwed from the assembly but couldn't not disengage from the targeting base.The locking boot can spin/turn within the targeting base but will not retract, likely due to thread stripping of the locking bolt but this cannot be seen without destroying the targeting base.Scratches were present on both the targeting base and locking bolt, likely from the multiple removal attempts indicated.The interfacing surfaces of the ulna nail and targeting base were smooth upon examination.Additional mdrs associated with this event.3025141-2021-00004: targeting base.3025141-2021-00005: locking bolt.
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Event Description
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During removal of an ulna rod and screws (removal for unknown reasons), the screws came out with no issues but the surgeon had difficulties removing the rod.Using two of the components of the targeting guide to help with removal, they were finally able to remove the nail after a 45 minute delay in surgery and use of a competitor's nail removal process.Once removed, the targeting guide components were cold welded to the nail and could not be separated.They are no longer usable.
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Search Alerts/Recalls
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