MAUDE Adverse Event Report: TEDAN SURGICAL INNOVATIONS, INC. PHANTOM RETRACTOR

Model Number	AL-0106
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Phantom retractor handle broke during use.Metal portion broken at tip.All broken parts retrieved, and patient remained safe and unharmed.

• Brand Name: PHANTOM RETRACTOR
• Common Device Name: RETRACTOR
• Manufacturer (Section D): TEDAN SURGICAL INNOVATIONS, INC.; 12320 cardinal meadow drive; suite #150; sugar land TX 77478
• MDR Report Key: 21066082
• Report Number: 21066082
• Device Sequence Number: 3418147
• Product Code: GAD
• UDI-Device Identifier: 00843059100969
• UDI-Public: (01)00843059100969
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2024
• Report Date (Section F): 12/23/2024

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: AL-0106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Date Report Sent to FDA: 12/23/2024