MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,3.5 BONE CUTTER FULL RADIUS,DISP SAW, POWERED, AND ACCESSORIES

Catalog Number 7210486

Device Problem Particulates (1451)

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

Event Date 06/25/2013

Event Type  Malfunction  

Manufacturer Narrative

The blade was returned. The device was evaluated microscopically and there was little to no evidence of galling at the inner blade tip. However, it was observed that the silver plating at the tips had delaminated. A review of the device history record was performed which confirmed no inconsistencies (b)(4). After the evaluation a root cause could not be determined. The company will continue to analyze additional complaints as they are reported. (b)(4).

Event Description

During a knee arthroscopy procedure it was reported that the device started shedding. The particulate was removed via suction with a shaver. There was a ten minute delay and no patient injury reported. A backup device was on hand.

• Brand Name: BLADE,3.5 BONE CUTTER FULL RADIUS,DISP
• 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: 4942489
• MDR Text Key: 23011470
• Report Number: 1219602-2015-00487
• 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: 07/27/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/27/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 01/31/2018
• Device Catalogue Number: 7210486
• Device LOT Number: 50710671
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/31/2013
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/28/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial