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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problem Mechanical Jam (2983)
Patient Problem Insufficient Information (4580)
Event Date 04/24/2020
Event Type  malfunction  
Manufacturer Narrative
The reported device, used in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and observed a discolored cable and motor housing and a broken lanyard. A functional evaluation revealed a jammed motor/ blade stall. The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product. A complaint history review concluded this was a repeat issue. The complaint was confirmed and the root cause has been associated with a mechanical component failure. Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that during a knee arthroscopy the shaver was not working at all. The procedure was successfully completed with a backup device, no significant delay or injuries were reported. Results of investigation have concluded that this unit had a jammed motor/blade stall error which makes it a reportable event.
 
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Brand NameMOTOR DRIVE UNIT HAND CNTRL PWRMX EL
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key11446461
MDR Text Key240578411
Report Number1643264-2021-00932
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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