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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 02/02/2024 |
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.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 2/2/2024, it was reported by a sales representative via (b)(4) that an ar-9236-02pp univers vaultlock glenoid trial center peg snapped off at the base of the trial while removing the glenoid trial.The surgeon pulled the broken center peg out with a different instrument, and the case was carried on and was completed successfully since this instrument was finished being used.This was discovered during an atsa procedure on (b)(6) 2024, with no reported patient harm.Additional information received on 2/9/2024: there was no case delay and the broken peg was easily pulled out of the patient without adverse effects.
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Search Alerts/Recalls
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