• 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. 4.5MM INCISOR PLUS PLATINUM 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. 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72203013
Device Problem Metal Shedding Debris (1804)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
Device investigation narrative - one 4. 5mm incisor plus platinum blade was returned for evaluation. Visual inspection identified significant axial fractures through the adapter body, to the outer sheath. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition. The inner blade showed slight abrasion at the distal tip and proximal end near the slough chamber. The outer blade showed slight abrasion at the distal tip. The condition of the device indicates the device received an excessive lateral load during use which caused the cracking resulting in a mis-alignment with the inner causing the reported shedding. Per the device ifu under precautions ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿. Further investigation is not warranted at this time. (b)(4).
 
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
It was reported that metal filings were coming out of the blade. No patient impact was reported.
 
Manufacturer Narrative
Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device. Further investigation is not warranted at this time. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name4.5MM INCISOR PLUS PLATINUM 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
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6496834
MDR Text Key141786175
Report Number1219602-2017-00395
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/04/2021
Device Catalogue Number72203013
Device Lot Number50624009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-