Model Number 17167-045; 17165 |
Device Problems
Entrapment of Device (1212); Mechanical Problem (1384); Separation Failure (2547); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
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Event Description
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Single step adapter and screw will not disassemble.Looks like the guidewire bent and got stuck in the screw and will not come apart.The surgeon attempted to disassemble for approximately 45 minutes; however, it will not come apart.
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Manufacturer Narrative
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Atec received a complaint on 05/12/2021 reporting the single step adapter and screw would not disassemble which resulted in a 45 minute delay in surgery.The invictus single step adapter (17165), mis reduction locking polyaxial screwdriver (17111), cannulated extended tab polyaxial reduction screw 6.5mm x 45mm (15025-065-045) & 45mm single step stylet, bevel (17167-045) were returned to atec on 05/17/2021.Visual inspection confirmed the instruments and implant were all assembled together and unable to be disassembled.The assembly was able to be disassembled by forcibly removing the stylet from the screw by malleting on the assembly while the stylet distal tip was held in a vice.The stylet had been bent/kinked at the distal end.This most likely occurred from exposing the stylet from the distal end of the screw and applying excessive lateral force to the stylet.The bend/kink create an interference with the cannulation of the screw preventing disassembly of the instruments and implant.
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Search Alerts/Recalls
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