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Catalog Number 530.605 |
Device Problems
Mechanical Problem (1384); Loss of Power (1475)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2015 |
Event Type
malfunction
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Event Description
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It was reported that during an unspecified surgical procedure, it was observed that the battery reamer/drill device was grinding inside and lost power.There were no delays to the planned surgical procedure as an identical spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device made a grinding noise while in use, failed cannulation, failed the power/torque test and did not get to full speed.It was further observed that the electronic control unit and the electronic motor did not function properly, the trigger components were damaged and there was rust and corrosion on the gear components.The reported condition was confirmed the assignable root cause was determined to be due to normal wear on mechanical and electronic components from repeated sterilization and use over time and inadequate cleaning and maintenance.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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