SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 72200872 |
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 10/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder procedure, the motor drive unit overheated.The procedure was successfully completed without delay using a back-up device.No patient injury or 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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H10 h3, h6: the reported device, used 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 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 dii and dii eip test control units with 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.A complaint history review concluded this was a repeat issue.Internal complaint reference: (b)(4).
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Search Alerts/Recalls
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