MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION MAX; REMOVABLE SHAFT

Model Number	UU202-03-0004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Screw driver tip broke during surgery.It was reported the surgeon did drill prior to implanting the screw but the bone was hard.The screw and driver tip were removed and a new screw was installed without further problems.The explanted screw and tip were thrown away at the surgical center.

• Brand Name: UNION MAX
• Common Device Name: REMOVABLE SHAFT
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): PRECISION MEDICAL TECHNOLOGIES, INC.; 2059 n pound dr; warsaw IN 46582
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 23623478
• Report Number: 3005823819-2025-00016
• Device Sequence Number: 18660243
• Product Code: KWQ
• UDI-Device Identifier: 00810076333762
• UDI-Public: 00810076333762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: UU202-03-0004
• Device Catalogue Number: UU202-03-0004
• Device Lot Number: 108795-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown