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

Model Number 7205317

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2020

Event Type  malfunction  

Event Description

It was reported that during a procedure, the blade had a foreign matter of black color attached when the package was opened.There was no delay in the case.No patient injury or other complications were reported.It is unknown how the procedure was finished.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One single 7205317 disposable ep-1 3.5mm razorcut blade used in treatment, was returned for evaluation.This device is sold as a box of six; not intended for individual sale.There was no outer damage observed.Abrasive wear and heat generated break down surface plating dip exposing underlying metal.The return showed rotational wear and heat discoloration from friction generated by side loading or pressure application.This causes the blade to rotate out of concentricity with the outer blade.The fine silt generated mixed with fluids creates a blackish oily looking substance as seen inside the cup of the outer blade tip.Per ifu: ¿irreversible damage will result from any attempt to disassemble curved blades.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running¿.Per instructions for use ¿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.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: RAZORCUT 3.5MM EP-1 DISP BLD
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10445902
• MDR Text Key: 204196251
• Report Number: 1219602-2020-01305
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251459
• UDI-Public: 03596010251459
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205317
• Device Catalogue Number: 7205317
• Device Lot Number: 50827958
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1