MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Model Number	72200082
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was shedding.No patient injury was reported.
Additional Manufacturer Narrative
One 5.5mm abrader burr was returned for evaluation.Visual assessment of the blade showed evidence of surface scoring on the inner id of the outer sheath.The heat shrink tubing that is applied to the inner burr shows signs of shedding.The burr appears to have been subjected to excessive side loading during use.

• Brand Name: BURR,5.5MM ABRADER,180MML DISPOSABLE (3
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7446021
• Report Number: 1219602-2018-00460
• Device Sequence Number: 13484718
• Product Code: HAB
• UDI-Device Identifier: 03596010541529
• UDI-Public: (01)03596010541529(17)200430(10)50694092
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: 04/30/2020
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Device Lot Number: 50694092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1