SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK ST; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number 72205138 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2023 |
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 an arthroscopy, the healicoil anchor broke when it was introduced into the bone.The procedure was completed without surgical 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).
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Manufacturer Narrative
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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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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 specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.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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Manufacturer Narrative
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H10: internal complaint reference (b)(4).
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.There is a non-s&n barcode label on the body of the device which reads, "(b)(4)".The distal anchor was not returned.The distal plug is still in the insertion tube.The insertion tube is bent, split and deformed on the end.The proximal anchor is broken and missing some ribs.There are no other visible deficiencies.A functional evaluation showed the black knob and orange knob will only partially turn due to the bend in the tube.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force upon insertion, or off-axial insertion.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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