It was reported that after an internal fixation surgery, performed on (b)(6) 2021, screws of meta-tan lag/comp kit 100/95 ((b)(4)) were used through an intertan 11.5mm x 20cm 125d ((b)(4)), leading to early implant failure.With some further investigation, it was discovered that there was no sales rep present at the original operation, and the error was made by a junior clinician at point of surgery.The surgeon and hospital do not blame the implants at all, and the metatan screws have now been more clearly labelled for future reference.This issue was resolved with a revision performed on (b)(6) 2021.
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The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, this represents a procedure complication and does not represent a device malfunction.Based on the information provided, the error was made by a junior clinician at point of surgery.According to the report, the metatan screws have now been clearly labelled, the surgeon does not blame the implants and the issue was resolved with a revision.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices 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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