MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT 3.5MM,EP-1,DISP BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205317

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that at the end of a knee scope using the razorcut 3.5mm blade the surgeon noticed dust like particles in the patient.No information has been provided regarding any surgical delay or interventional actions taken as a result of the alleged findings.No patient injury was reported as a result of the alleged event.

Manufacturer Narrative

Device investigation narrative - two used and one unused 3.5mm razorcut blades were returned for evaluation.Visual assessment of the used blades using a stereo microscope showed surface scoring, however no visible evidence of material galling or debridement was observed.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt on all devices.Each blade was evaluated for dimensional conformance and found to meet specifications.No root cause related to the manufacturing process can be established.Further investigation is not warranted at this time.Device returned for evaluation.Device evaluated by the manufacturer.Evaluation codes updated.(b)(4).

• Brand Name: RAZORCUT 3.5MM,EP-1,DISP BLD
• Type of Device: SAW, 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 ; 5123585706
• MDR Report Key: 5573734
• MDR Text Key: 42536996
• Report Number: 1219602-2016-00190
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: 7205317
• Device Lot Number: 50921744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other