MAUDE Adverse Event Report: CTL MEDICAL CORPORATION; DISC SHAVER

Model Number 103.7154

Device Problem Fracture (1260)

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

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Disc shaver material cracked at the junction of the ring and the neck of the distal tip.Overall instrument material remains fully intact.

• Type of Device: DISC SHAVER
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer Contact: tracy bui ; 4550 excel parkway; addison, TX 75001
• MDR Report Key: 15655470
• MDR Text Key: 302589084
• Report Number: 3009051471-2018-00029
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 103.7154
• Device Lot Number: 7KHFA-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1