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Model Number 71934993 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Article: harper, a., sparavalo, s., ma, j., & wong, i.(2022).Fixation type does not affect the learning curve and short-term radiographic outcomes for arthroscopic anatomic glenoid reconstruction with distal tibia allograft.Arthroscopy, sports medicine, and rehabilitation, 4(2), e371-e379.
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Event Description
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It was reported that on literature review "screw versus double endobutton fixation of the allograft for arthroscopic anatomic glenoid reconstruction in the treatment of recurrent anterior shoulder dislocation", 1 patient had a re-dislocation after a glenoid bone repair procedure using a round endobutton device.The dislocation was resolved with a glenoid reconstruction using distal tibia allograft with screw fixation.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H10: attachment provided named "article" in report (b)(4) is incorrect.There is no pdf of the literature at the moment for this event.
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Manufacturer Narrative
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H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the correct journal article was not provided for review.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported cannot be determined.Therefore, no further clinical/medical assessment can be rendered.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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