It was reported that during surgery, the compression screw did not enter the brocade guide and showed rebound to enter the sliding screw.At the end, no compression screw is placed, distal locking was not performed, nail insertion arch was removed, the sliding screw blocked and 0 mm plug placement was performed, which also does not fit properly into the intertan intramedullary nail.No injury reported.
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The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.Factors and/or potential probable causes that could contribute to the reported event have been identified in the risk management file, possible as tolerance stack up, part geometry, over-use, excessive force applied, use of older model guides/sleeves, and geometry allows drill to drill deeper than intended.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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