The reported event (final screwing impaired after impaction) could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: -visually, the security screw was received loose in the glenoid sphere.Probably due to several attempts to loosen the central safety screw during the surgery, the hexagonal footprint of the safety screw was found damaged and the polished surface of the sphere was found severely scratched with several large and deep scratches.-functionally, the sphere could correctly impact and tighten into a ø25mm baseplate with no issue to report.The issue described in the reported event was unable to be reproduced.The sphere was functional.A review of the device history for the reported lot did not indicate any abnormalities.During manufacturing, functionality test and dimensional inspection were done according to specifications.All devices met the specifications.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The absence of the peripheral groove around the baseplate, the remained soft tissues between the baseplate and the glenoid sphere or inside the baseplate threading hole are the most probably causes for the reported event.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate use of the hcp (a functional test showed that the device was functional).If any additional information is provided, the case will be reassessed.
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