ARTHREX, INC. 5.5X28MM PERIPHERAL SCREW, LOCKING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Model Number 5.5X28MM PERIPHERAL SCREW, LOCKING |
Device Problems
Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/11/2021 |
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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It was reported that the surgeon was attempting to do a 10 degree augmented mgs glenoid with a 35mm central post.After impacting the glenosphere onto the baseplate, the patient's glenoid fractured and the entire construct came loose (see attached picture).The surgeon was not sure if they were too anterior with their initial guide pin and subsequent reaming, possibly weakening the bone anteriorly.The surgeon also went bi-cortical in the vault with the central post ((b)(4)) and did not know if this ultimately led to the failure.The surgeon was able to use bone graft from the patient's resected humeral head to address the glenoid fracture and then implanted a non-augmented mgs baseplate and finished the procedure without further issue.
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