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Model Number 72203345 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that active heel traction boot replacement kit was loosening and it was not maintaining tension on the boot causing the patients foot to slide, ultimately impacting distraction.This was noticed before the procedure; therefore, no patient was involved.A backup device was available and no delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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