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Model Number UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
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.
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Event Description
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On 01/30/2024, it was reported by a sales representative via (b)(4) that an ar-9236-02pp univers vaultlock¿ glenoid trials central peg snapped off.This occurred during a total shoulder procedure on (b)(6) 2024 when the central peg of the trial snapped off when the surgeon was attempting to remove it from the glenoid.Since they were done using it after that, they no longer needed it during that case.The surgeon immediately found the broken piece and handed it off to the scrub tech along with the trial itself.There was no delay in the case and no effect on the patient.
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Search Alerts/Recalls
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