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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT NON-HAND CNTL PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200617
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem Burn(s) (1757)
Event Date 02/28/2019
Event Type  Injury  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
It was reported that, before starting a meniscal resection, the motor drive unit hand control was so hot that it burned the sheet on the patient and produced smoke. A back-up device was available to use instead, but it is unknown if the procedure was successfully completed. The surgery was delayed more than half an hour. As consequence of the alleged malfunction, the patient suffered two burn areas in the thigh.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. No relevant supporting clinical / medical information or photos have been provided; therefore a thorough clinical analysis cannot be rendered. A relationship, if any, between the subject device and the reported event could not be determined. A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. The dyonics handpieces instructions for use cautions to avoid patient burns, do not place the handpiece on the patient when it is not in use. It also states not to operate the handpiece in the open air for an extended period, as lack of irrigation may cause the motor or blade to overheat and seize. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand NameMOTOR DRIVE UNIT NON-HAND CNTL PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8531832
MDR Text Key142504159
Report Number1643264-2019-00283
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number72200617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/19/2019 Patient Sequence Number: 1
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