MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM NAVIGATION; NAVIGATED SCREWDRIVER FOR POLYAXIAL SCREW, NON-CONNULATED, SR 20, 1/4" SQUARE

Model Number	UU062-84-0100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the case the doctor was implanting a 6.5mm screw and was hitting resistance when the tip broke off.The drive tip remained in the screw, so the doctor helicoptered the screw out and replaced it with a new one, using a backup driver.The patient was not affected and procedure proceeded as normal.

• Brand Name: MOMENTUM NAVIGATION
• Common Device Name: NAVIGATED SCREWDRIVER FOR POLYAXIAL SCREW, NON-CONNULATED, SR 20, 1/4" SQUARE
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH AND CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 24569228
• Report Number: 3005823819-2026-00006
• Device Sequence Number: 12850913
• Product Code: OLO
• UDI-Device Identifier: 00814386025812
• UDI-Public: 00814386025812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200845
• 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): 03/11/2026

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: UU062-84-0100
• Device Catalogue Number: UU062-84-0100
• Device Lot Number: U029053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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: 51 YR
• Patient Sex: Female