MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 2.9, MAG-MINI, DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	72201518
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, when the abrader was inserted and as it approached the joint, the outer tube bent and the inner blade broke.No backup device was available.No delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one single 72201518 disposable 2.9mm mini magnetic abrader blade used for treatment, was returned for evaluation.These are sold as a box of six.This product is not intended to be sold individually.This is a small scale blade for delicate application.The outer blade component was found creased.There were also wear bands on the surface of the inner blade.Both conditions indicated excess pressure contributed to the damage and collapse of the blade.Skiving is a symptom of excessive side loading and can create shedding.There were signs of poor material excision which is user controlled by suction and irrigation adjustment.This is a small scale device which is not intended to have excess pressure applied.Per instruction 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 blade¿.Complaint history review indicated no similar allegation for the lot number reported.Dhr/batch/lot review did not indicate a condition or product, procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: ABRADER, 2.9, MAG-MINI, DISP. BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9438952
• Report Number: 1219602-2019-01528
• Device Sequence Number: 19653885
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: 03596010621672
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 03/02/2021
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50718397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1