MAUDE Adverse Event Report: SMITH AND NEPHEW INC. ENDOSCOPY DIVISION SMITH AND NEPHEW SUTURE PASSER; ACCESSORIES, ARTHROSCOPIC

Lot Number 2039696

Device Problem Defective Component (2292)

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

Event Date 11/27/2019

Event Type  malfunction  

Event Description

Suture passer failed, trigger not working.Fda safety report id # (b)(4).

• Brand Name: SMITH AND NEPHEW SUTURE PASSER
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH AND NEPHEW INC. ENDOSCOPY DIVISION
• MDR Report Key: 9410778
• MDR Text Key: 169512513
• Report Number: MW5091415
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019

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 Lot Number: 2039696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR