• 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, 3.5, 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, 3.5, MAG-MINI, DISP. BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72201519
Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2018
Event Type  Malfunction  
Event Description

It was reported that pieces of metal were flying off of them while being used in a case. The pieces felt off into the patient's anatomy, all the pieces were removed from the patient. Back-up device was available. As per customer response there was no harm to the patient.

 
Manufacturer Narrative

One single 72201519 disposable 3. 5mm mini magnetic abrader blade returned. These are sold as a box of six. This product is not intended to be or tested to be sold individually. The complaint stated: "it was reported that pieces of metal were flying off of them while being used in a case. The pieces felt off into the patient's anatomy, all the pieces were removed from the patient. Back-up device was available. As per customer response there was no harm to the patient. " the blade is in relatively good condition with exception of small dings on the blade bulb edges and light circular scratches around the distal diameter of the inner shaft. Although light, the degradation of the surface could create light metallic debris. This is a small scale device which is not intended to have pressure applied. No root cause related to the manufacture of the device was established. Complaint history search revealed no other complaints for this production lot.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameABRADER, 3.5, MAG-MINI, DISP. BLADE
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, TX 78735
5123585706
MDR Report Key7787277
MDR Text Key117257043
Report Number1219602-2018-01075
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2019
Device MODEL Number72201519
Device Catalogue Number72201519
Device LOT Number50631209
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/09/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-