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

Model Number	7205317
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10445902
• Report Number: 1219602-2020-01305
• Device Sequence Number: 4016161
• Product Code: HAB
• UDI-Device Identifier: 03596010251459
• UDI-Public: 03596010251459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2024
• Device Model Number: 7205317
• Device Catalogue Number: 7205317
• Device Lot Number: 50827958
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1