SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that, during set up for a hip arthroscopy procedure, the mdu displayed a sensor error on the screen.No significant delay and a back up was available to complete the procedure.No other complications were reported.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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The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Event Description
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It was reported that, during set up for a hip arthroscopy procedure, the mdu displayed a sensor error on the screen.The motor drive unit was not working at all, no movement on the instrument or burr.No significant delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Search Alerts/Recalls
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