MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE 3.5 MAG-MINI DI; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201514

Device Problem Material Fragmentation (1261)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a knee arthroscopy, there were metal shavings or fragments noted while using the incisor plus elite.All fragments removed by suction.The procedure was successfully completed without surgical delay using the same faulty device.No further complications were reported.

• Brand Name: INCISOR PLUS ELITE 3.5 MAG-MINI DI
• 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: 19169446
• MDR Text Key: 341054767
• Report Number: 1219602-2024-00868
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010624932
• UDI-Public: 03596010624932
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201514
• Device Lot Number: 51184561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 12/02/2023
• 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