It was reported that during surgery the threads on the cannulated impactor- med got stripped.There was no delay, and a s&n back up device from another tray was available to complete the procedure.No injuries reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device got stripped and has signs of wear and tear from use.The device was manufactured in 2012.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.
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