SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 72204410 |
Device Problems
Break (1069); Fracture (1260); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3: the sample is under evaluation by the manufacturing site.
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Event Description
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It was reported that during an arthroscopy, the biorsure screw was weakened.When passing the screw, it became unthreaded and remained smooth.The procedure was completed with non-significant delay using a competitor device.No further complications were reported.Upon investigation, it was found a fracture of the threads of the proximal third of the device.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection revealed that the device was not in its original packaging.The screw had deformation and fracture of the threads of the proximal third of the device.There was bio debris clogging the threads through the device.Based on the condition of the product material found during visual inspection, additional material testing was not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A review of the anchor 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.A risk management review found that the reported failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failures include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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