MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL,CONCAVE EP-1 (BX 3); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205335
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, it was found that label states item is a concave, but it is actually a convex blade.The device was used on the patient.A backup device was available to complete the procedure with no delay and no patient injuries.
Additional Manufacturer Narrative
The reported full radius blade concave blades were not returned for evaluation.A trend of this nature has been observed with this product in the field, prompting a corrective action investigation.This error results in the cutting window being located incorrectly relative to the bend.As an immediate response to this complaint, a quality alert was issued and a retraining of the machine operators to the manufacturing process was performed.In addition a root cause investigation has been opened to address this failure mode.

• Brand Name: FULL RADIUS BL,CONCAVE EP-1 (BX 3)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8762800
• Report Number: 1219602-2019-00783
• Device Sequence Number: 14112811
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 07/06/2021
• Device Catalogue Number: 7205335
• Device Lot Number: 50779861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1