MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,4.0MM,FLAT TOP,180MM LG, HIGH VISI SAW, POWERED, AND ACCESSORIES

Catalog Number 72203130

Device Problems Particulates (1451); Metal Shedding Debris (1804)

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

Event Date 08/26/2013

Event Type  Malfunction  

Manufacturer Narrative

One used burr was returned for evaluation. Visual inspection identified significant axial fractures through the adapter body, to the outer sheath. A contact point on a section of the sheath at the end of the tube coupled with corresponding debridement of the inner tube opposite the contact point was observed. All indications point to excessive lateral load during device rotation. The device was inspected dimensionally and found to meet design requirements. Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition. A review of the device history record was performed which confirmed no inconsistencies (method code 3317). After the evaluation the root cause was undetermined. The company will continue to analyze additional complaints as they are reported. (b)(4).

Event Description

During a hip arthroscopy it was reported that the burr was reportedly shedding in the joint. The particulate was flushed out and a backup device was available to complete the procedure. A one minute delay, no patient injuries or complications were reported.

• Brand Name: BURR,4.0MM,FLAT TOP,180MM LG, HIGH VISI
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4945280
• MDR Text Key: 23105381
• Report Number: 1219602-2015-00529
• Device Sequence Number: 1
• Product Code: HAB
• 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,CONSUM

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/28/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/28/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2014
• Device Catalogue Number: 72203130
• Device LOT Number: 50629117
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/03/2013
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/01/2011
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial