MAUDE Adverse Event Report: CTL MEDICAL CORPORATION PICASSO II; BONE TAP

Lot Number 6F9ED

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Taps were disposed of at hospital and not returned to manufacturer.Unable to investigate and confirm failure.

Event Description

Tip of 6.5 diameter tap broke.

• Brand Name: PICASSO II
• Type of Device: BONE TAP
• Manufacturer (Section D): CTL MEDICAL CORPORATION; 4550 excel parkway; addison TX 75001
• Manufacturer Contact: tracy bui ; 4550 excel parkway; addison, TX 75001
• MDR Report Key: 15477473
• MDR Text Key: 303544685
• Report Number: 3009051471-2017-00006
• Device Sequence Number: 1
• Product Code: HWX
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 6F9ED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1