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); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2021 |
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 use instruments inside the patient in a tendon achilles repair, they started with 2.5 drill bit to create a pilot hole in order to screw in anchor suture to the target lesion.When anchor placement insert release the needle from the handle ultrabraid suture was lacerated.And it was unable to stitch the tissues.The procedure was completed with a s+n back-up device.A significant delay was reported, and no other complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H3, h6: the reported device, used in treatment.Was not received for evaluation, thus functional testing could not be completed.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided image confirmed suture was lacerated and broken.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 concluded this was a repeat issue.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 review of the suture material specifications found a material certification is required with each lot.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed include excessive force causing laceration.No containment or corrective actions are recommended at this time.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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Event Description
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It was reported that during use instruments inside the patient in a tendon achilles repair, they started with 2.5 drill bit to create a pilot hole in order to screw in anchor suture to the target lesion.When anchor placement insert release the needle from the handle ultrabraid suture was lacerated.And it was unable to stitch the tissues.The procedure was completed with a s+n back-up device.A delay greater than 30min was reported, and no other complications were reported.
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Search Alerts/Recalls
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