MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL,4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210499

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

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

Event Date 04/19/2013

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device has not been returned (method code and results code).Due to this fact we are unable to determine what may have caused the user to experience the reported incident.A review of the device history record was performed which confirmed no inconsistencies (method code).In the event the samples are returned for evaluation the complaint will be reopened for additional investigation.(b)(4).

Event Description

During a knee scope procedure, it was reported that the blade was shedding in the joint.The metal particulate was removed from the joint space via suction.A backup device was available mitigating the five minute delay.No patient injury was reported.The device was disposed of so no product is available for analysis.

• Brand Name: DISPOSABLE BL,4.5MM FR ELITE
• 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: 4950671
• MDR Text Key: 23138086
• Report Number: 1219602-2015-00590
• 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
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 7210499
• Device Lot Number: 50676832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2015
• Date Device Manufactured: 08/07/2012
• 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