|
Model Number 71692801 |
Device Problem
Display or Visual Feedback Problem (1184)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/04/2020 |
Event Type
Injury
|
Event Description
|
It was reported that, during procedure, while the meta tibial intramedullary nail was implanted, sureshot was used to lock the distal end of the nail, and the screen had no response.The procedure was finished using a changed in the surgical technique: the screw was inserted free handed; as consequence, surgery was delayed about 1 hour.The patient has been discharged from the hospital.
|
|
Event Description
|
It was reported that during procedure when the meta tibial intramedullary nail was implanted, sureshot was used to lock the distal end of the nail, and the screen had no response.A delay of 1 hour was reported, no impact to the patient for the delay.The procedure was finished using a changed in the surgical technique.The device was insert free handed.
|
|
Manufacturer Narrative
|
Results of investigation: it was reported that during procedure when the meta tibial intramedullary nail was implanted, sureshot was used to lock the distal end of the nail, and the screen had no response.The procedure was successfully completed with a change in surgical technique using free-hand to insert the screw, resulting in a 1 hour delay with no impact to the patient.The associated sureshot targeter, intended for use in treatment, was returned and evaluated.Visual inspection of the returned product found damage on the cord.A serial number was provided and the review of the manufacturing records for the listed serial number did not reveal any deviation from the standard manufacturing processes.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which recognized the device.However, a coil continuity test revealed that one of the coils was broken.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.This is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Damage from repeated use can occur and some causes for the malfunction would include a broken cable, damaged connector, broken srom connection, and/or silicone overmolding failure.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Our investigation found that the subject device has been previously evaluated for similar events and an upgrade to the targeter has taken place.A second generation targeter has been released and is available (please reference device 71692851) for use.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
|
|
Search Alerts/Recalls
|
|
|