ARTHREX, INC. ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM
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Model Number ECLIPSE TRUNION 51MM, SLOTTED, TPS CAP |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2022 |
Event Type
Injury
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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 (b)(6) 2023, it was reported by a sales representative via email that while using an ar-9301-03 arthrex eclipse cage screw large, an ar-9400-sbk eclips speedscap implant system and an ar-9301-51cpc eclipse trunion, during the final steps, the surgeon drilled the pilot hole into the screw and fixation was compromised.Surgeon moved to an apex system instead.While using the apex, fixation was also compromised when trailing the head, so surgeon used a larger size instead.Additional information requested.
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Search Alerts/Recalls
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