MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 5.5MM ELITE ABRADER BURR; SAW, POWERED, AND ACCESSORIES

Model Number	72200723
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that metal shavings came off the burr.All pieces were removed from the patient.No patient injuries were reported.
Additional Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: DYONICS 5.5MM ELITE ABRADER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 6813063
• Report Number: 3003604053-2017-00082
• Device Sequence Number: 138843
• Product Code: HAB
• UDI-Device Identifier: 03596010578013
• UDI-Public: (01)03596010578013(17)210916(10)50621374
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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 Model Number: 72200723
• Device Catalogue Number: 72200723
• Device Lot Number: 50621374
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1