MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BEAVER BLADE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72203307

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 06/11/2013

Event Type  malfunction  

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Further investigation into breakage of the beaver blades found the root cause to be related to a design issue.This product is no longer being manufactured or distributed by smith & nephew.Product remaining in the field is being removed per recall #z-0793-2016.No additional actions are required at this time.

Event Description

During a hip arthroscopy procedure the blade broke off in patient.Dr.Used a grasper to retrieve the broken piece.No patient complications reported.

• Brand Name: BEAVER BLADE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 5904749
• MDR Text Key: 53935616
• Report Number: 3003604053-2016-00044
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/18/2013

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 72203307
• Device Lot Number: 3030178
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2013
• Initial Date FDA Received: 08/25/2016
• Date Device Manufactured: 12/28/2012
• 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