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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
Model Number 72200617
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  malfunction  
Event Description
It was reported that, during a shoulder arthroscopy, the "mdu powermax elite shaver" was not being recognized by the shaver console, additionally, sometimes it stopped working and displays that the shaver was unplugged.In consequence, it was unplugged and it worked again.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
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 recognition failure 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 and without footswitch.Mdu recognition failure 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.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.
 
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Brand Name
MOTOR DRIVE UNIT NON-HAND CNTL PWRMX
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10273991
MDR Text Key198878120
Report Number1643264-2020-00563
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010551559
UDI-Public03596010551559
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200617
Device Catalogue Number72200617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Date Manufacturer Received08/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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