SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72202615 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
Event Type
malfunction
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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 after a proximal hamstring repair, twinfix ultra device had a labeling issue, since it appeared to be a 4.5mm and it was a 5.5mm.In addition it was noticed that device was used expired.No further complications reported.
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Manufacturer Narrative
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H10: h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.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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