• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/1901
Event Type  Malfunction  
Manufacturer Narrative

The reported device, intended for use 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 observed no issues. A functional evaluation revealed a blade stall. The complaint was not verified 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. 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. No containment or corrective actions are recommended at this time.

 
Event Description

It was initially reported that the mdu did not plug in. No case involved; therefore, there was no patient involved. The results of investigation have concluded that this unit had a blade stall error, which makes it a reportable event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10342010
MDR Text Key201698822
Report Number1643264-2020-00714
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
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 Reuse

-
-