SMITH & NEPHEW, INC. TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 7210707 |
Device Problems
Break (1069); Insufficient Information (3190); Material Split, Cut or Torn (4008)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Foreign zip code: (b)(6).Internal complaint reference (b)(4).
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Event Description
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It was reported that, during a foot procedure, the needles came off from the twinfix anchor while tying the knots and or passing.Also some suture breakage was experienced.Mayo needles had to be used.It is unknown how the procedure was completed.No significant delay was reported.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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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 specification upon release for distribution.A complaint history review found no similar reported events.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.A clinical review states that based on how the anchor is used, it is not likely that the needles would have been left behind within the patient, but this was not confirmed or communicated so it must be assumed that the needle was left behind.The material 420 stainless steel has good biocompatibility in a variety of invasive, limited duration contact applications, however this needle is not approved for implantation; therefore, long-term implantation data is not available.If retained the patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.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.Corrected information in h6 (health effect - clinical code | health effect - impact code | medical device problem code | component code).
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