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Model Number AT2-C12-S |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing and inspection records were reviewed, and no anomalies were found.The returned 12.0mm, micro acutrak 2® bone screw was examined visually under magnification.There appeared to be scratches on the screw head and white/tan material between the threads at the tip.Functional tests exhibited that both returned drivers can be inserted and removed from the screw by hand.Sticking of the drivers was confounded due to the twist in the hex tips.Due to unknown procedural conditions, no definitive conclusion on the cause of the incident can be made.
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Event Description
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It was reported that during the procedure when the surgeon removed the screwdriver from the screw after inserting the screw, the screw was pulled out from the bone due to the strong fixing force between the screw and the screwdriver.The screw was used for the talus.Because of the larger hole in the bone, the surgeon could no longer use the micro screws.Therefore, he switched to the mini screw.This report is related to report numbers 3025141-2022-00104 and 3025141-2022-00105 which are for the other devices involved in this event.
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Search Alerts/Recalls
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