MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,4.0,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205324
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used 4.0 mm abrader burr was returned for evaluation.Visual assessment of the device showed the polycarbonate components are melted causing the reported seizing.The likely cause of the seizing is due to improper fluid flow during use.Per the device instructions for use under warnings ¿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 device did not meet product specifications upon release into distribution.(b)(6).
Event or Problem Description
It was reported that during the surgery, when using the blade of the shaver it stopped working and the part that fits in the handpiece was melted.It is unknown if there was a backup device available.No delay or patient injury reported.Results of investigation have concluded that the device melted due to an overheating which makes it a reportable event.

• Brand Name: ABRADER,4.0,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9097913
• Report Number: 1219602-2019-01150
• Device Sequence Number: 2424999
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/20/2019

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: 03/02/2023
• Device Catalogue Number: 7205324
• Device Lot Number: 50718319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR