• 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. BLADE,MINI,INCISOR,2.9MM,DSPL 6/BX 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. BLADE,MINI,INCISOR,2.9MM,DSPL 6/BX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7209065
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure, the device was not working due to it did not cut. A significant delay was reported. Is unknown if a backup device was available and no patient injuries were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBLADE,MINI,INCISOR,2.9MM,DSPL 6/BX
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8646961
MDR Text Key146350271
Report Number1219602-2019-00625
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeCO
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 06/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7209065
Device Lot Number50747279
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-