DEPUY SYNTHES POWER TOOLS CAD II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 511.701 |
Device Problems
Partial Blockage (1065); Defective Device (2588)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
No Answer Provided
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Manufacturer Narrative
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(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to device wear from normal use and servicing.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 the motor on the compact air drive device was blocked, seized and rough running.It was further determined that the device failed pre-test for function of soft mode switch.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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The manufacturer location was documented as (b)(4) in the initial report.The location has been updated to (b)(4).Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.Mfg date: the device manufacture date was documented as april, 17, 20017 in the initial report.It has been updated to december 5, 2012.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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