Model Number 03.52.10.0723 |
Device Problems
Defective Component (2292); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Batch review performed on 12 october 2021: lot 2054556a: (b)(4) items manufactured and released on 16-feb-2021.No anomalies found related to the problem.To date, no other similar events have been reported.Another instrument involved: batch review performed on 12 october 2021: must lt 03.52.10.0709 quick screw driver - long or short lot.2054547: (b)(4) items manufactured and released on 04-mar-2021.No anomalies were found related to the problem.To date, no other similar events have been reported.
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Event Description
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During the primary spine surgery, the surgeon was not able to load the must lt screw to the modular screwdriver.It was unclear if the modular screwdriver was broken or assembled incorrectly.The surgeon used instead the quick screwdriver and loaded correctly the must lt screw.After inserting the quick screwdriver (with the attached must lt screw), the surgeon was not able to remove the screwdriver from the screw.The surgery was completed successfully using a competitor screw system with 30 minutes of delay in the surgery.
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Manufacturer Narrative
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On november 05th we received the items involved in the event.Visual inspection performed by r&d project manager: the surgeon was not able to couple the implant with the polyaxial screwdriver.The surgeon had to abandon using the modular screwdriver and opted to use the quick screwdriver.The surgeon was able to load the must lt screw onto the quick screwdriver.However, after inserting the quick screwdriver the surgeon was not able to remove the screwdriver from the screw.The parts involved in the complaint have been checked and tested with positive results detecting any sort of not conformity.
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Search Alerts/Recalls
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