MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO II; ROD INSERTER

Model Number 016.7051

Device Problem Crack (1135)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

After the rod inserter was returned and inspected there was a noticeable tear at the distal tip of the instrument and the resulting tear is still attached to the proximal shaft.The tear was not reported in the original communication.The cause for this can only be speculated given it was not reported by the end user.The instrument could have been subject to excessive forces during the transporting process or dropped during handling, which could lead to the such tear.Additionally the instrument could have been used as a counter torque during set screw insertion that puts stress at this point and could have led to a tear failure over time.It is highlighted in the stg that the counter torque instrument should be used instead when tightening the set screw.Used surgical technique was not reported and patient anatomical features are unknown.There was no harm or injury reported to the patient.Cause is indeterminate.

• Brand Name: PICASSO II
• Type of Device: ROD INSERTER
• 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: 15764725
• MDR Text Key: 304592429
• Report Number: 3009051471-2022-00011
• Device Sequence Number: 1
• Product Code: LXH
• 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: 11/09/2022

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 Operator: Health Professional
• Device Model Number: 016.7051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1