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

Model Number	72203127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7446023
• Report Number: 1219602-2018-00461
• Device Sequence Number: 11081106
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)190125(10)50612810
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1