MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,4.0,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205324
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the device was used to shave the glenoid cavity, it made the metal flake.The procedure was completed with a back-up device with no delay or patient injury.
Additional Manufacturer Narrative
One used 4.0 abrader burr was returned for evaluation.Functional inspection confirmed the inner burr rotated freely within the outer sheath, no friction was felt in the unloaded condition.Visual inspection of the sheaths entire id and the inner burrs cutting edges was performed using an arthroscope and a stereo microscope, no evidence of shedding was observed.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ABRADER,4.0,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8915027
• Report Number: 1219602-2019-00994
• Device Sequence Number: 19333006
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• 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): 09/18/2019

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: 03/02/2023
• Device Catalogue Number: 7205324
• Device Lot Number: 50718319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1