It was reported that the lag screw drill sleeve and the intertan 3.2 mm guide pin sleeve are sticking together, so they won't slide properly.No injury to the patient reported.Is it unknown how the procedure was finished, when the event occur and if there was a delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
H3, h6: the associated device, intended for use in treatment, was returned, and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has burrs and gouges causing the device to stick together and not function properly.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
|