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

Model Number	UU062-83-0100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision case the surgeon had already removed a 7.5mm screw and was replacing it with an 8.5mm screw when the tip of the driver broke off in the tulip head.After this occurred the surgeon explanted the screw.The hospital disposed of the screw with the tip still inside.The patient was not affected.

• 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: 24014748
• Report Number: 3005823819-2026-00001
• Device Sequence Number: 21478635
• Product Code: OLO
• UDI-Device Identifier: 00814386025782
• UDI-Public: 00814386025782
• 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): 01/08/2026

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: UU062-83-0100
• Device Catalogue Number: UU062-83-0100
• Device Lot Number: U031372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/08/2026
• 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: Female