MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Model Number 72203127

Device Problem Metal Shedding Debris (1804)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

One 72203127 disposable high visibility 5.5mm 180mm long abrader burr product device was received for evaluation.Per the complaint this device was used for a hip arthroscopy procedure.There is skiving/wear band on the outer diameter of the inner blade proximal surface.This is symptomatic of excessive side loading.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.The burr still spins freely at this time but debris from skiving contributes to binding and potential seizing of the inner and outer components.This is a large scale cutting product which requires adequate irrigation to properly excise materials.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials.It must be ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Root cause related to the manufacture of the device was not confirmed.

Event Description

It was reported that the device has metal shaving from burr.Procedure was completed with a smith-nephew back-up device.No patient injury reported.

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX
• MDR Report Key: 7446023
• MDR Text Key: 106142791
• Report Number: 1219602-2018-00461
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)190125(10)50612810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2019
• Device Model Number: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50612810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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