Catalog Number 130760000 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that delta extend glenosphere would not screw into metaglenes.The star 20 screw driver got stuck into central post.Doe: on (b)(6) 2024 affected side: right shoulder.
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Manufacturer Narrative
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Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot :the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d4 (exp date), h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information was received: - patient consequences extended the surgery time.-both glenosphere and metaglene were attempted to be used in same case and in both metaglene.- inhance was used in combination with delta, after the delta extend.
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Search Alerts/Recalls
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