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Model Number 71674001 |
Device Problems
Naturally Worn (2988); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during trauma surgery, a trigen drill guide handle was noticed to be worn out and broken.This was observed outside the patient.Surgery was resumed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H6: the device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.Per photo attachment the failure mode confirms that the device is broken.A complaint history review found related failures; 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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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Search Alerts/Recalls
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