MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL,4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Model Number	7210499
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the blade was shedding.All debris was removed with suction.A backup device was available to complete the procedure with a short delay.No patient impact was reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

• Brand Name: DISPOSABLE BL,4.5MM FR ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7079022
• Report Number: 1219602-2017-01505
• Device Sequence Number: 11087130
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: (01)03596010494764(17)210801(10)50613721
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 08/01/2021
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50613721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1