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

Catalog Number 010640

Device Problem Contamination (1120)

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

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an arthroscopy there was rust present on the tip of the blade.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

Additional information was received from reporter stating that the device was not used in the patient.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 SERRATED FLAT(BX 5)
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8957995
• MDR Text Key: 156390744
• Report Number: 1219602-2019-01090
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010032713
• UDI-Public: 03596010032713
• 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: 10/03/2019

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: 06/28/2023
• Device Catalogue Number: 010640
• Device Lot Number: 2017740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1