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Model Number 72200755 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, a twinfix titanium 5.0 ultrabraid was implanted due to rotator cuff injury, after the surgery a re-examination was performed and it showed that the nail was loose and the fixation was not firm, therefore, a second operation was performed in order to remove the nail.The nail was successfully removed using tweezers.It is unknown if there was an available backup device.No delay was reported.No further complications were reported.
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Manufacturer Narrative
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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 way to determine if the device contributed to the reported event.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 was documented appropriately and there were no indications to suggest the anticipated risk is not adequate.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.It was communicated that the patient¿s conditional following the second procedure was normal.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was not confirmed.Factors that could have contributed to the reported event include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.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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