SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK NST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72205137 |
Device Problem
Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Date 10/30/2020 |
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 surgery, internal to the patient, the healicoil knotless anchor cracked upon insertion.It is unknown how the procedure was completed and if there was a delay.No patient injury or other 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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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.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 risk management files found that the reported failure was documented appropriately.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).
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