MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE STONECUTTER BURR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200728
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was overheating.No patient injury was reported.
Additional Manufacturer Narrative
One (b)(4) dyonics 4.0mm elite stonecutter burr device returned.The product sluff chamber and adapter body has symptoms of melting.Noisy/grinding and overheating/melted material conditions have 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.There is physical evidence of bone/tissue and/or metal shavings not excising efficiently.As a result, binding and melting occurred.Root cause related to the manufacture of the device was not confirmed.Correction.
Event or Problem Description
It was reported that the dyonics was overheating.A backup device was available to complete the procedure with no delay and no patient injuries.

• Brand Name: DYONICS 4.0MM ELITE STONECUTTER BURR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8080917
• Report Number: 1219602-2018-01577
• Device Sequence Number: 1579329
• Product Code: HAB
• UDI-Device Identifier: 03596010578068
• UDI-Public: 03596010578068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 01/11/2019

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 Catalogue Number: 72200728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1