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

Catalog Number 7205335

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/16/2019

Event Type  malfunction  

Event Description

It was reported that during a surgery, the device had the right labelling outside the box and package but when the device was opened, the material was not the ones that they use.It was a different part of what the customer ordered.The device was used by error.A backup device was available to complete the procedure successfully.Delay or patient injuries were not reported.

Manufacturer Narrative

The device in question will not be returned for evaluation however, four unused full radius concave blades were returned for referenced complaint (b)(4).Visual assessment of the blade confirmed the reported complaint.The bend orientation (convex instead of concave) is incorrect.This error results in the cutting window being located incorrectly relative to the bend.

• Brand Name: FULL RADIUS BL,CONCAVE EP-1 (BX 3)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8652638
• MDR Text Key: 146497050
• Report Number: 1219602-2019-00640
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251626
• UDI-Public: 03596010251626
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

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: 07/06/2021
• Device Catalogue Number: 7205335
• Device Lot Number: 50779861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1