MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISP KNIFE ROUND TIP (BX 5); ACCESSORIES,ARTHROSCOPIC

Model Number 010620

Device Problem Insufficient Information (3190)

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

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during hip arthroscopy, the acufex would not fit down on the blue hip scope cannula, one of the blades had a wider handle.No backup device was available.It is unknown if a delay was caused due to the device malfunction.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: additional information was received from reporter stating that there was a back-up device available to complete procedure.Although a device malfunction, the procedure was finished as intended without any other medical intervention with an equivalent device, with no significant delay or complication.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: DISP KNIFE ROUND TIP (BX 5)
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9516548
• MDR Text Key: 173174335
• Report Number: 1219602-2019-01620
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010032690
• UDI-Public: 03596010032690
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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: 01/30/2024
• Device Model Number: 010620
• Device Catalogue Number: 010620
• Device Lot Number: 2027581
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1