The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The locking head on the device is heavily damaged from attempted use.The clinical medical evaluation concluded that, per complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, this incident occurred during use outside of the patient.Reportedly, it was necessary that new bone holes were created, and a new titanium plate and screws were implanted into the patient.The subsequent modified procedure was completed satisfactorily.The impact to the patient beyond that which has already been reported cannot be determined at this time.Should any additional relevant clinical information become available, the case will be re-evaluated.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include a procedural variance or improper surgical technique.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.
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