MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION FIRST PASS MINI SUTURE PASSER; ACCESSORIES, ARTHROSCOPIC

Model Number 72290128

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/05/2020

Event Type  Injury  

Event Description

Pt underwent a left medial meniscal repair.Pt reported for a post operative appointment for routine x-ray.Some type of density was found which appeared to be foreign and or manmade.The decision was made to return to surgery to remove the foreign body before causing a reaction or causing damage to the knee.The fb upon removal appeared to be the teeth of one of the suture passing devices that was used during the repair.Fda safety report id# (b)(4).

• Brand Name: FIRST PASS MINI SUTURE PASSER
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION
• MDR Report Key: 11515188
• MDR Text Key: 241024835
• Report Number: MW5100095
• Device Sequence Number: 1
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/16/2021

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 Model Number: 72290128
• Device Catalogue Number: 72290128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR