MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 3.5 CURVED CONCAVE FULL RADIUS; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210980

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a knee arthroscopy, the shaver got clogged, tech went to unclog it and noticed the tip on the inside of the full radius blade had broken off inside the shaver sheet.No pieces were left in the patient, they were not in the patient freely.Another blade was opened and the same thing happened.The procedure was completed without surgical delay using a smith and nephew back up device.No further complications were reported.

• Brand Name: BLADE 3.5 CURVED CONCAVE FULL RADIUS
• 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: 19168676
• MDR Text Key: 340974585
• Report Number: 1219602-2024-00865
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010595775
• UDI-Public: 03596010595775
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210980
• Device Lot Number: 51169563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 09/29/2023
• 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