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

Catalog Number	72201507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8538412
• Report Number: 1219602-2019-00445
• Device Sequence Number: 1743955
• Product Code: HAB
• UDI-Device Identifier: 03596010621665
• UDI-Public: 03596010621665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 04/22/2019; 05/31/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 04/23/2019; 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1