MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM SYN PLAT CONC CURVED BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number 72205110

Device Problem Flaked (1246)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that during a knee arthroscopy, the surgeon noticed a loose metal fleck on the side of the synovator platinum blade.The blade was pulled out from the knee joint and the metal fleck was wiped off.No piece fell inside the joint, since the surgeon noticed the problem in time.The procedure was completed using the same reported device.There was a surgical delay less than 30 minutes and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

• Brand Name: 4.5MM SYN PLAT CONC CURVED BLD
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: 18692175
• MDR Text Key: 335308738
• Report Number: 1219602-2024-00271
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205110
• Device Lot Number: 50860706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Date Device Manufactured: 03/04/2020
• 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