SMITH & NEPHEW, INC. DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72201881 |
Device Problems
Separation Failure (2547); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
Event Type
Injury
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Event Description
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It was reported that during use in ucl repair procedure, the dynomite anchor came out of the bone instantly, also the needles attached to the anchors were kind of stuck so it was a little struggle to get the anchors out.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: b5 and b7 updated.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 specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 per case details the anchors came out of the bone and the procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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.
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Event Description
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It was reported that during use in ucl repair procedure, the dynomite anchor came out of the bone instantly, also the needles attached to the anchors were kind of stuck so it was a little struggle to get the anchors out.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up devices in the same bone holes.No further complications were reported.
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Search Alerts/Recalls
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