ARTHREX, INC. ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM
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Model Number ECLIPSE TRUNION 43MM, SLOTTED, TPS CAP |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/07/2020 |
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.
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Event Description
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It was reported that during an arthroplasty total shoulder using the eclipse, when using the central screw on the trunion, the screw locked up, which removed the central core of bone.They used the apex stem to completed the case.Additional information obtained 9/15/20: when screwing the central screw in the two components locked causing the trunion to spin and the core of bone to come off in the central screw.The surgeon then chose to abort using the planned eclipse and instead implanted an apex stem to complete the procedure.
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Manufacturer Narrative
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Complaint not confirmed, the device was found to be undamaged.It fit the returned ar-9301-02 cage screw without difficulty and was found to meet dimensional specifications.No abnormality was found on the device that may have contributed to the event.
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Search Alerts/Recalls
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