• 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. ABRADER 2.9 MAG-MINI DISP. 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. ABRADER 2.9 MAG-MINI DISP. BLADE; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201518
Device Problems Break (1069); Dent in Material (2526); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that during an arthroscopy, a white material of the tip of the abrader torn, it was part of the inner blade.And it also broke on the upper part of the blade.The procedure was completed without delay using a back-up device.No further complications were reported.
 
Manufacturer Narrative
H6: the reported device was received for evaluation.A visual inspection revealed that it is not in its original packaging.The white polyester shrink tubing on the inner shaft is cut and scuffed.The inner shaft is fractured toward the distal end.The outer shaft is dented at the cutting window and the interior of the hub is damaged at the insertion point for the inner shaft.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ABRADER 2.9 MAG-MINI DISP. BLADE
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key18872226
MDR Text Key337470765
Report Number1219602-2024-00439
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010621672
UDI-Public03596010621672
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72201518
Device Lot Number51037243
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/10/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-