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Model Number 71674001 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It was reported that, during surgery, while using outside the patient, was noticed that the drill guide handle was out of alignment.No surgical delays nor injuries to the patient were reported.It is unknown how the procedure was finished.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Results of investigation: the device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the device appears to be excessively worn, rendering it inoperable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.The device is manufactured in 2008.At this time, we do not have 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.We consider this investigation closed.
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Search Alerts/Recalls
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