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

Model Number 72201518

Device Problem Flaked (1246)

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

Event Date 12/15/2017

Event Type  malfunction  

Event Description

It was reported that the device was shedding or flaking.No patient injuries were reported.

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
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7154037
• MDR Text Key: 96120504
• Report Number: 1219602-2017-01610
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621672
• UDI-Public: (01)03596010621672(17)200725(10)50676478
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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