SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72200752 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2021 |
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, during procedure, the screw of the twinfix backed off antes implantation.Procedure was completed, after a non-significant delay, with a back-up device.No further complications were reported.
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Event Description
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It was reported that, during shoulder cuff repair surgery, the screw of the twinfix backed off after implantation.The anchor was removed from the patient using tweezers.Procedure was completed, after a non-significant delay, with a back-up device.No further complications were reported.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and there is debris on the device.There are no signs of damage or deficiencies on the device.A functional evaluation could not be performed due to the condition in which the device was received.A review of the customer provided image found the anchor with sutures.No damage or deficiencies can be seen.The complaint was not confirmed, and the root cause could not be determined.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.
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Search Alerts/Recalls
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