SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/09/2019 |
Event Type
malfunction
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Event Description
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It was reported that during a hip scope surgery, the hand piece device got hot because the motor was overheating.A backup device was available to complete the procedure with no significant delay and no patient injuries.
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Manufacturer Narrative
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The device 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 overheating could not be reproduced.Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions.Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch.Overheating did not occur during functional testing.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.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.
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Event Description
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It was reported that during a hip scope surgery, the hand piece device got hot because the motor was overheating.A backup device was available to complete the procedure with no delay and no patient injuries.
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Search Alerts/Recalls
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