MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE POWER-MINI DISP 2.9; ARTHROSCOPE

Catalog Number 72201513

Device Problem Insufficient Information (3190)

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

Event Date 06/23/2023

Event Type  Injury  

Event Description

It was reported that during a wrist arthroscopy procedure, unspecified flaws were noted on the incisor plus.The procedure was successfully completed with no surgical delay, applying a change in the surgical technique, an open surgery was performed.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that no clinical documentation was provided for this investigation.Based on the limited information provided, the surgeon¿s dissatisfaction with medium wrist stabilization kits unspecified flaw led to the decision not to perform the arthroscopic procedure on the patient and change to an open surgery.It was reported, the surgeon successfully completed the procedure without a surgical delay and the patient¿s health was not affected.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: INCISOR PLUS ELITE POWER-MINI DISP 2.9
• Type of Device: ARTHROSCOPE
• 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: 17663348
• MDR Text Key: 322421791
• Report Number: 1219602-2023-01669
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010604972
• UDI-Public: 03596010604972
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K172092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 72201513
• Device Lot Number: 51088620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Date Device Manufactured: 12/03/2022
• 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 Sex: Female