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Catalog Number 23510110 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".
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Manufacturer Narrative
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The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received screwdriver bit, long was visually inspected, and we can see that the across corner region of the hex is damaged it is deformed with a material line to the right side from the across line which indicates excessive force application while the screw extraction.This is visible in the locking screw head where we can see misalignment with the head and application of excessive force.It was also seen that left-handed helix threads are also flattened which is feasible from holding it with high force.Further, the dimensional analysis was conducted and the device was within the specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing, or design-related problems were found during the investigation.Based on the above investigation the root cause can be attributed to user-related that the deformation of the hex was caused by the application of excessive force.If any additional information is provided, the investigation will be reassessed.
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Event Description
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As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".
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Search Alerts/Recalls
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