MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE; PASSER

Catalog Number 7209485

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that during a knee surgery, the lasso of the set meniscus mender was introduced into the needle put into the knee of the patient to get back a thread.By trying to remove the system, the tip of the lasso remained in to the patient knee.The surgeon succeeded to get it back (no damage for the patient).The procedure was completed with a delay of 15 minutes.There is no information available of the back up of the set meniscus mender.No further complications were reported.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19215590
• MDR Text Key: 341503262
• Report Number: 1219602-2024-00909
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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 Catalogue Number: 7209485
• Device Lot Number: 2131828
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/30/2024
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 72 KG