MAUDE Adverse Event Report: CTL MEDICAL CORPORATION MONET; DRILL BIT

Model Number 113.7724

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/23/2021

Event Type  malfunction  

Event Description

Acif drill bit was bent at distal tip.No mention if it was bent prior to surgery.No patient anatomy provided.Case was complete.Potential cause can be user error for not keeping the axis of the instrument steady while drilling.

• Brand Name: MONET
• Type of Device: DRILL BIT
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer (Section G): CTL MEDICAL CORPORATION; 4550 excel pkwy; ste 300; addison TX 75001
• Manufacturer Contact: nicole conforti ; 4550 excel pkwy; ste 300; addison, TX 75001 ; 2145455820
• MDR Report Key: 15821720
• MDR Text Key: 307777649
• Report Number: 3009051471-2021-00013
• Device Sequence Number: 1
• Product Code: HTW
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 113.7724
• Device Lot Number: AFNCC
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1