• 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 Problems Motor(s) (486); Power Cord (497); Defective Component (2292); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

The device 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 no issues were found. A functional evaluation revealed the power cord had a short. The complaint was confirmed and the root cause has been associated with an electrical component failure. 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.

 
Event Description

It was reported that the motor was bad. According to product evaluation, the power cord shorted out. No case involved. No injuries were reported.

 
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 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 Key7733533
MDR Text Key115577438
Report Number1643264-2018-00563
Device Sequence Number0
Product Code HAB
Combination Product (Y/N)
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2018
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 Manufacturer06/25/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-