• 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. ACROMIONIZER,4.0 EP-1,DSPL BL 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. ACROMIONIZER,4.0 EP-1,DSPL BL SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205326
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2017
Event Type  malfunction  
Event Description
It was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking. A backup device was available to complete the procedure with no patient injuries. Per customer¿s response the device ran continously.
 
Manufacturer Narrative
One 7205326 4. 0mm ep-1 disposable acromionizer blade returned. The complaint allegation stated: ¿it was reported that during procedure the acromionizer device presented its blade ribbing against the metal sheath with no shedding or flaking. A backup device was available to complete the procedure with no patient injuries. Per customer¿s response the device ran continuously. ¿ the blade was tested with a dyonics handset and showed no irregularities. The device produced a typical whirring sound of the inner blade rotations. The complaint could not be duplicated. It could have been temporary difficulty with excising of tissue and bone fragments. Returns of this nature have been found to be consistent with the device being ¿tested¿ with insufficient or without irrigation and suction. No root cause related to the manufacturing of this device was established.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACROMIONIZER,4.0 EP-1,DSPL BL
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 west william cannon drive
austin 78735
MDR Report Key7526697
MDR Text Key108867764
Report Number1219602-2018-00611
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
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 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205326
Device Catalogue Number7205326
Device Lot Number50645208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-