MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,3.5,DSPL,BURR BOX/6; SAW, POWERED, AND ACCESSORIES

Model Number	3819
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while utilizing abrader 3.5mm (c/n: (b)(4)), it was confirmed that the rotation speed was slowed even though the surgeon had set the maximum rpm setting.They couldn¿t resect the patient bone and the rotation of blade could be visible by the naked eye.They tried to reboot the control unit and reconnected the blade to the hand-piece, however the problem couldn¿t be resolved.They stopped to resect the patient bone and the procedure was finished only resection of the synovial tissue.There was a 10 minutes delay in the procedure.No patient injury reported.
Additional Manufacturer Narrative
One 3.5 abrader burr was returned for evaluation.Visual assessment showed no abnormalities.Functional assessment was performed using a dyonics power shaver system control unit and a dyonics mini-motor handpiece.The burr operated as intended no variance in rpm was observed.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not required at this time.

• Brand Name: ABRADER,3.5,DSPL,BURR BOX/6
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7238834
• Report Number: 1219602-2018-00188
• Device Sequence Number: 1185501
• Product Code: HAB
• UDI-Device Identifier: 03596010118882
• UDI-Public: (01)03596010118882(17)220515(10)50664367
• 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,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 05/15/2022
• Device Model Number: 3819
• Device Catalogue Number: 3819
• Device Lot Number: 50664367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1