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

Catalog Number 7205324

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  malfunction  

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 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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9097913
• MDR Text Key: 159355064
• Report Number: 1219602-2019-01150
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR