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Catalog Number 530.605 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and determined that the control unit was not functioning.Therefore, the reported condition was confirmed.It was further determined that motor control was defective and leaking.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that control unit was not functioning on the battery reamer/drill device.It was further observed that the motor control was defective and leaking.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.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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