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Model Number 24MM +4 LAT BASEPLATE, MODULAR |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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Event Description
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On 3/5/2024, it was reported by a sales representative via phone that an ar-9560-24-4 baseplate and an ar-9561-30s central screw came apart during insertion.This was discovered during a revers total shoulder procedure on (b)(6) 2024.The press was used to press down both devices together.The physician assistant verified that it was between the minimum and maximum.However, when the surgeon inserted the baseplate and central screw in the patient, they came apart.The surgeon was not far into the surgery yet and was able to remove the baseplate and central screw easily.The surgeon was not confident in the integrity of the devices and did not want to try to put them back together again; instead, the case was completed using a new ar-9560-24-4 baseplate and an ar-9561-30s central screw.The patient was not affected.
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Search Alerts/Recalls
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