SMITH & NEPHEW, INC. TWINFIX ULTRA HA 4.5 W/2 UB (WH & BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 72202597 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that during a reconstructive acl, however unknown if internal or external to the patient, a twinfix ultra fractured.It is unknown if there was any delay or how was the surgery completed.No further complications were reported.
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Manufacturer Narrative
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H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specification found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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