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Model Number 71674001 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2021 |
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, the bowed of a drill guide handle split and that pieces were falling/crumbling out.Incident occurred during a spd audit.No case reported; therefore, there was no patient involvement.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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H3, h6: the device, intended for use in treatment, was returned for evaluation.Our investigation included a visual inspection of the device which confirms that the epoxy coating over the internal witness wire has degraded and has begun to come off.This failure mode has been previously identified.Since the manufacturing of the complaint device, design changes have been implemented to eliminate the occurrence of this failure.The device was manufactured in 1995.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, corrective and preventive action is indicated to mitigate future recurrence of similar events.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; 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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