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Catalog Number 05.001.202 |
Device Problems
Bent (1059); Break (1069); Component Falling (1105); Device Inoperable (1663); Dent in Material (2526)
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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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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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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Event Description
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It was reported by (b)(4) that during service and evaluation, it was observed that locking components were damaged on the motor device.It was noted in the service order that the device was not working, had no function, the bracket was badly bent, there were dents in the groove behind the bracket and there was fall damage.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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Manufacturer Narrative
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(b)(4).Device manufacture date: the device manufacture date was inadvertently missed in the initial report.It has been updated as dec 1, 2010.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and noted that the housing was broken off and the motor and control unit were defective.Therefore, the reported condition was confirmed.The assignable root cause was due to improper handling, which is user error/misuse/abuse.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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Search Alerts/Recalls
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