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

Model Number	ED72201520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were pieces of metal flying off of them while it was being used in a case.No patient injury was reported.All the pieces were removed from the patient.
Additional Manufacturer Narrative
One single (b)(4) disposable 2.9mm mini magnetic barrel abrader blade returned.These are sold as a box of six.This product is not intended to be or tested to be sold individually.The complaint stated: "it was reported that there were pieces of metal flying off of them while it was being used in a case.No patient injury was reported.All the pieces were removed from the patient." the shafts of the inner as well as the outer blades are bowed.They spin, but with resistance and drag.This condition is a symptom of excessive side loading.This is a small scale device which is not intended to have pressure applied.Per ifu: "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".It was also noted that the inner blade friction sleeves are out of location.There are light ding marks on the blade edges.No other abnormalities were reported for this manufacturing lot.No root cause related to the manufacture of the device was established.

• Brand Name: BARREL ABRADER,POWER-MINI, DISP,2.9
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7783094
• Report Number: 1219602-2018-01067
• Device Sequence Number: 2336369
• Product Code: HAB
• UDI-Device Identifier: 03596010656049
• UDI-Public: (01)03596010656049(17)191114(10)50631214
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 11/14/2019
• Device Model Number: ED72201520
• Device Catalogue Number: ED72201520
• Device Lot Number: 50631214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1