SMITH & NEPHEW, INC. TWINFIX ULTRA TI 4.5 W/2 UB (WH & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202893 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during procedure, the anchor of the twinfix was fixed and when tying the first knot, the twinfix anchor loosened.Procedure was resumed, without any delay, with the same device.No further complications were reported.
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Manufacturer Narrative
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H2: additional information ¿a1, a2, a3¿.
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Event Description
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It was reported that, during shoulder arthroscopy, the anchor of the twinfix was fixed and when tying the first knot, the twinfix anchor loosened.Procedure was resumed, without any delay, with the same device.No further complications were reported.
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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.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.There was no relationship found between the device and the reported event.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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