It was reported that, after a intramedullary surgery on (b)(6) 2021, a revision surgery was made on (b)(6) 2021 because an incorrect metatan intergrated lag was screwed into the intertan construct (boxes between intertan & metatan lag screws are almost identical to look at).Current health status of the patient is unknown.
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.We are currently unable to rule out human error as a contributing factor to the reported events.Should any additional clinical information be provided this complaint will be re-evaluated.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the label specification for meta-tan and for intertan was conducted and it revealed the information regarding the product, such as part number, name, and size, was found to be clear, legible, and complete in both labels.A review of the risk management files revealed that this failure mode and associated harm has been identified and the anticipated risk level is still adequate.The product meets the specifications at the time of manufacture.Possible causes could include but not limited to user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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