MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,5.5MM ABRADER,180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Model Number	72200082
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip scope the burr used started spitting out blue stuff.No patient injury reported.
Additional Manufacturer Narrative
One 72200082 disposable 5.5mm 180mm abrader burr product returned.This was identified as demo device.The burr still spins semi freely due to the sluff chamber beginning to melt.This is where the "blue" fragments are coming from as the chamber melts and pulls fragments into the blade.This is a large scale cutting product which requires adequate irrigation to properly excise materials.Per ifu: "periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials.Per ifu: "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.

• Brand Name: BURR,5.5MM ABRADER,180MML DISPOSABLE (3
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7651726
• Report Number: 1219602-2018-00850
• Device Sequence Number: 10807132
• Product Code: HAB
• UDI-Device Identifier: 03596010541529
• UDI-Public: (01)03596010541529(17)200224(10)50681538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 02/24/2020
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Device Lot Number: 50681538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1