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

Catalog Number	72200729
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).One shelf carton of (qty 6) 72200729 dyonics 5.5mm elite stonecutter burr devices used for treatment, was returned for evaluation.The complaint states: ¿the device was noisy during use.¿ the product showed symptoms of excess heat generated.There were blue particles on the washer.The adapter body shoulder had begun to break down, shed and become distorted at the collar from excess heat generated.This did not occur with a newly opened burr.Product was tested and performed as expected.There were no unusual observations.The blade connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.Noisy, grinding and overheating, melted material condition has been found to be consistent with devices being tested/run without or with inadequate suction/irrigation.Suction is controlled by the pump settings.The larger burr requires adequate irrigation to properly excise materials and keep cool.Per ifu: ¿ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials.¿ binding, shavings and seizing may occur due to bone/tissue plastic or metal shavings/fragments not excising efficiently.These are not to be tested without irrigation and suction.No root cause related to the manufacturing of the device was established.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that the device was noisy during use.A test was performed: change of handpiece and of the console, but no significant improvement was shown.A backup device was available to complete the procedure with no significant delay or patient injuries.Results of the investigation have concluded that this unit showed symptoms of excess heat generated and overheating which makes it a reportable event.

• Brand Name: DYONICS 5.5MM 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: 9153005
• Report Number: 1219602-2019-01199
• Device Sequence Number: 16924899
• Product Code: HAB
• UDI-Device Identifier: 03596010578075
• UDI-Public: 03596010578075
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 10/03/2019

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 Expiration Date: 02/13/2024
• Device Catalogue Number: 72200729
• Device Lot Number: 50787270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1