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Model Number 71692801 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, during surgery, after connecting to the host, a trigen sureshot targeter displayed "sureshot targeter invalid or broken tool, please exchange!" and could not be used normally.The free hands were used to complete the surgery.After the in vitro test, it was confirmed that there is no navigation signal.Surgery was resumed with a change in surgical technique.It is unknown if there was a delay.
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Event Description
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It was reported that, during closed reduction and internal fixation of femur surgery, after connecting to the host, a trigen sureshot targeter displayed "sureshot targeter invalid or broken tool, please exchange!" and could not be used normally.The free hands were used to complete the surgery.After the in vitro test, it was confirmed that there is no navigation signal.Surgery was resumed, after a non-significant delay, with a change in surgical technique.Additional anesthesia was required due to the delay.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use.However, a functional evaluation of the returned device confirmed the stated failure mode.After plugging the device into a monitor, an error message was displayed, rendering the device inoperable.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints 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 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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, a broken wire in the targeter cable, bent pins in the connector or an open circuit on the data line 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 future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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