MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO; K-WIRE

Model Number 100.7009

Device Problem Material Separation (1562)

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

K-wire broke as screw was being turned down after being placed onto it.Surgeon was placing the screw over the k-wire and bent the k-wire.When he turned the screw down, it forced the k-wire forward and the k-wire broke.The part was left in the patient, as it would cause more harm to take it out.The broken part was left in the patient.As the part is made of nitinol, this is of no harm to the patient.No pre or post-op x-rays were provided.No patient anatomy was provided.No harm or injury to the patient was reported.Case was comepleted.User error.

• Brand Name: PICASSO
• Type of Device: K-WIRE
• 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: 15814063
• MDR Text Key: 307662341
• Report Number: 3009051471-2021-00028
• Device Sequence Number: 1
• Product Code: HXI
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 100.7009
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1