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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 06/01/2018 |
Event Type
Injury
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Event Description
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It was reported that in the literature review "arthroscopic latarjet procedure with double-button fixation: short-term complications and learning curve analysis"; 1 patient required a conversion to open surgery because of diffuse soft tissue bleeding during an arthroscopic latarjet procedure where a double endobutton was used.The patient outcome is unknown, and no further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).Doi: doi.Org/10.1016/j.Jse.2017.12.007 bonnevialle, n., thélu, c.E., bouju, y., vogels, j., agout, c., duriez, p., & azoulay, v.(2018).Arthroscopic latarjet procedure with double-button fixation: short-term complications and learning curve analysis.Journal of shoulder and elbow surgery, 27(6), e189-e195.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.Insufficient product identification information was provided and thus a complaint history review could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided, and thus, a risk management review could not be conducted.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient impact beyond that which was reported cannot be determined.The patients¿ outcome or current health status was not provided.Therefore, no further clinical/medical assessment can be rendered.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.¿.
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Search Alerts/Recalls
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