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Model Number DISPS KIT,TRANS-TIB ACL W/ SAWBLD |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2023 |
Event Type
malfunction
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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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Event Description
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On 8/18/2023, it was reported by a sales representative via sems that an ar-1897s transtibial acl disposables kit had 2 of 5 guide pins that did not come with the beath pin in them.This was discovered upon opening the package during a procedure, with no reported adverse event or patient harm.Additional information requested.
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Search Alerts/Recalls
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