Model Number T10 HEXALOBE, CMP FT |
Device Problems
Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/15/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022, it was reported by a facility representative via email that an ar-8730-46h mini compression ft screw after being advance about three fourths of the way the screw stopped and would not advance any longer.The screw was stuck and would not back out either, the tip of an ar-8737-38 driver broke while attempting to remove it.A second driver was able to remove the screw with a lot of force and torque this cause the driver tip to warp and the screw to bend but did not complete break.This was discovered during a metacarpal fraction procedure on (b)(6) 2022.
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Manufacturer Narrative
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Complaint confirmed.Upon visual inspection, it was noted that the distal tip of the device was twisted and broken.The broken piece was not returned for investigation.Relevant dimensions could not be measured due to the damage to the device.
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Search Alerts/Recalls
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