MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS, 2.9, MAG-MINI, DISP. BLA; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201507

Device Problem Break (1069)

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

Event Date 04/17/2019

Event Type  malfunction  

Event Description

It was reported that the shaft broke during surgery but not inside the patient.No patient injury or delays were reported.It is unknown how the procedure was completed since no backup device was available.No further information is available.

Manufacturer Narrative

One single 72201507 disposable 2.0mm full raduis mini magnetic abrader blade returned.These are sold as a box of six.This product is not intended to be sold individually.The complaint stated: ¿the shaft broke during surgery but not inside the patient.¿ the blade is damaged.The inner and outer blade shafts have been fractured from the sluff chamber portion of the product.The shafts are bowed.This is a small scale device which is not intended to have excess pressure applied.

• Brand Name: FULL RADIUS, 2.9, MAG-MINI, DISP. BLA
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8538412
• MDR Text Key: 142738752
• Report Number: 1219602-2019-00445
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621665
• UDI-Public: 03596010621665
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2019

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: 05/14/2021
• Device Catalogue Number: 72201507
• Device Lot Number: 50735488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/22/2019; 05/31/2019
• Supplement Dates FDA Received: 04/23/2019; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1