MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE STONECUTTER BURR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72200728
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 72200728 dyonics 4.0mm elite stonecutter burr device returned.The product has become over heated and the sluff chamber and adapter body have begun to melt.Noisy/grinding and overheating/melted material condition has been found to be consistent with the device being tested/run without or with inadequate suction/irrigation.This device is not intended to be engaged without suction either.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).This can cause bone or tissue fragments to not be excised efficiently.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).Root cause related to the manufacture of the device was not confirmed.
Event or Problem Description
It was reported that the blade made a noise when the device is rotating.No patient injury reported.Back-up device was used to complete the surgery.According to investigation results, the product has become over heated and the sluff chamber and adapter body have begun to melt.

• Brand Name: DYONICS 4.0MM ELITE STONECUTTER BURR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8129876
• Report Number: 1219602-2018-01646
• Device Sequence Number: 10826007
• Product Code: GEI
• UDI-Device Identifier: 03596010578068
• UDI-Public: 03596010578068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Catalogue Number: 72200728
• Device Lot Number: 50715141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1