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

Catalog Number	72200728
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 4.0 elite stonecutter burr was returned for evaluation.Visual assessment of the device showed the beginning stages of material transfer of the thrust washer to the adapter body.The burr was tested using an ep-1 mdu and run at 5000 rpm and the device exhibited a screeching noise.The screeching noise that is heard is a result of the various materials heating up with one another which results from excess friction against the sluff chamber, thrust washer and adapter body components.When the irrigation feature is not utilized during normal operations of the device, the various materials start to breakdown and melt which causes the loud screeching noise; this loud noise is typically heard just prior to the components within the device seizing up making it nonfunctional at that time.When the blade was tested using irrigation no unusual noise was heard.Per the device instruction for use under warning ¿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 were no indications that would suggest that the devices did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a procedure, the blade made noise when the device is rotating.Backup device was available to complete the procedure.No delay and no patient injuries were reported.Results of the investigation have concluded that this unit overheated which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 9218863
• Report Number: 1219602-2019-01318
• Device Sequence Number: 16683703
• 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
• Report Date (Section B): 10/22/2019

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: 07/16/2023
• Device Catalogue Number: 72200728
• Device Lot Number: 50747360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1