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 Foreign Body In Patient (2687)

Event Date 12/07/2017

Event Type  malfunction  

Event Description

It was reported that the surgeon noticed metal shreds coming off burr while performing a hip arthroscopy.Surgeon made all effort to remove as much sheddings.Surgeon tried to remove all metal shreds/particles out of patient's hip.Suction and flushing performed, some metal particles were not removed as stuck in good/healthy tissue even if flushing and suction performed.Another burr was opened for use and procedure was completed without further incident.

Manufacturer Narrative

Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.A review of the (b)(4) database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified no additional complaints for this manufactured lot of this nature.

• 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 78735
• MDR Report Key: 7104094
• MDR Text Key: 94671269
• Report Number: 1219602-2017-01533
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655899
• UDI-Public: (01)03596010655899(17)191124(10)50666269
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2019
• Device Model Number: 72203127
• Device Catalogue Number: 72203127
• Device Lot Number: 50666269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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: 31 YR