• 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. ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE 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. ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205668
Device Problems Overheating of Device (1437); Vibration (1674); Knife (3156); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2019
Event Type  Malfunction  
Manufacturer Narrative

Foreign post code - (b)(6).

 
Event Description

It was reported that, during a shoulder arthroscopy, the blade heated up and vibrated with a strange noise. A back-up device was available to complete, without delay, the procedure. The patient did not experience any adverse consequence.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8643131
MDR Text Key146231767
Report Number1219602-2019-00604
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205668
Device Catalogue NumberUNKNOWN
Device LOT Number50724367
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 Received02/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-