It was reported that during an acl reconstruction, three (3) bone plugs broke and disintegrated while being inserted into the tibial tunnel, the broken pieces were removed by using curettes.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes and no further complications were reported.
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Internal complaint reference case-(b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found six bone tunnel plugs, five bone tunnel devices are broken and one of the bone tunnels does not appear to be broken.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 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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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