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

Model Number	72201518
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was shedding or flaking.No patient injuries were reported.
Additional Manufacturer Narrative
One single 72201518 disposable 2.9mm mini magnetic abrader blade returned.These are sold as a box of six.This product is not intended to be or tested to be sold individually.Customer feedback indicated that there was no patient involved.The device is used.The single returned device.It is in relatively good condition with exception of some skiving at the distal tip.The outer blade has a light wear band on its outer diameter.The outer blade has a light wear band on its inner diameter.This condition is a symptom of excessive side loading and can produce light shedding.This is a small scale device which is not intended to have pressure applied.No root cause related to the manufacture of the device can be established.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: 7154037
• Report Number: 1219602-2017-01610
• Device Sequence Number: 18856872
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: (01)03596010621672(17)200725(10)50676478
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 07/25/2020
• Device Model Number: 72201518
• Device Catalogue Number: 72201518
• Device Lot Number: 50676478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1