Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint # (b)(4).Investigation summary: patient was revised due to loosening of metaglene and glenosphere.Screws were also broken.Patient also experienced pain and possible infection.There was no surgical delay.Doi- (b)(6) 2012 dor- (b)(6) 2023 affected side- right shoulder.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment "20_jul_2023_22_03_37_10593".Visual analysis of the photos revealed the threaded section of the dxtend screw lock d4.5x24mm covered with what appears to be organic material and blood residues.However, based on the quality of the photo and the blood residues no signs of breakage nor loosening can be observed on the device.In order to confirm loosening more evidence is required.The overall complaint was not confirmed as the observed condition of the dxtend screw lock d4.5x24mm would not contribute to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot, a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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