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Model Number 71677095 |
Device Problems
Fitting Problem (2183); Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case (b)(4).
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Event Description
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It was reported that, during an internal fixation surgery, the lag/comp screw kit 95/90 threads were not allowing the driver to engage the screw.Surgery was resumed, with a back-up device.It is unknown if there was any delay as consequence of this allegation.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A functional evaluation of the returned device could not confirm the stated failure mode.The device functioned as intended.A review of complaint history did not reveal additional complaints for the listed batch.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.Possible probable causes could include but are not limited to user error or rough handling.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.
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Search Alerts/Recalls
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