It was reported that, during a cori assisted tka surgery, the ri bone pins 4 mm x 127 mm was blunt and was not getting into the bone easily, the surgeon needed to force it and it bent.The procedure was finished with a smith and nephew back up devices without delay.No further complications were reported.
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H3, h6: the ri bone pins 4 mm x 127 mm qty: 4, part number rob10010, intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be confirmed with a visual inspection.The images provided did not confirm the device is dull.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with wear and tear as a result of repeated use.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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