SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 72203697 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Osteopenia/ Osteoporosis (2651)
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Event Date 12/05/2023 |
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 during an arthroscopy, the healicoil rsb anchor was pulled out due to the osteoporotic bone of the patient and the device was used after its expiration date.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).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 no 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 clinical review states that the root cause of the reported events was the result of poor bone quality for the bone pull out and human error stemming from lack of a review of the manufacturer¿s expiration date on the packaging for the use post expiration.It is the responsibility of the end-user to confirm the expiration and integrity of the product/packaging prior to patient use.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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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 no 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.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.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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