SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that the speed of the motor drive unit turns on by itself.Incident occurred before an arthroscopy.There was no delay and a back up device was available.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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H10.H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of turning on by itself could not be reproduced.Product did not start by itself during functional testing but did fail for motor stall error.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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 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 complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.H11.Corrected information in b5.
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Event Description
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It was reported that the speed of the motor drive unit turns on by itself.Incident occurred before an arthroscopy.There was no delay and a back up device was available.Results of investigation have shown the unit failed functional testing for motor stalled error which is a reportable event.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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