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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
Model Number ED72200616
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 03/12/2020
Event Type  malfunction  
Event Description
It was reported that during a revision knee scope the motor drive unit stopped working.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.
 
Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The re-assessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
Event Description
It was reported that during a revision knee scope the motor drive unit stopped working.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.Results of investigation confirmed that the forward button was not working which makes a reportable event.
 
Manufacturer Narrative
H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
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 no issues.A functional evaluation revealed a button was stuck and would not activate the motor causing a hand piece error.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 found related failures; this failure mode will be trended to assess for any necessary corrective actions.The complaint was confirmed and the root cause has been determined to be mechanical component failure.Factors that could have contributed to the event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time.
 
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Brand Name
MOTOR DRIVE UNIT HAND CNTRL PWRMX EL
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key9979605
MDR Text Key188322123
Report Number1643264-2020-00217
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010555472
UDI-Public03596010555472
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberED72200616
Device Catalogue NumberED72200616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Date Manufacturer Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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