MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM; SCREWDRIVER, SR 20, 1/4" SQUARE

Model Number	UU052-30-0200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a case, the surgeon broke 5 drivers in the attempt to install and then remove a screw.The surgeon did not tap line to line prior to implanting the screw.After breaking all drivers, the surgeon used another manufacturer's instrument to realign the trajectory of a screw and began hammering on the instrument which caused the screw to break.All pieces of the screw were retrieved but were not returned to uusa.The patient was not affected.No further information was available for the manufacturer of the screw used.The available information did not allow us to determine whether a serious injury could result from the driver breakages, a medical device report was submitted for each screwdriver.

• Brand Name: MOMENTUM
• Common Device Name: SCREWDRIVER, SR 20, 1/4" SQUARE
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ARCAMED; 5101 decatur blvd.; indianapolis IN 46241
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 25362693
• Report Number: 3005823819-2026-00009
• Device Sequence Number: 15948804
• Product Code: NKB
• UDI-Device Identifier: 00814386025041
• UDI-Public: 00814386025041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191932
• 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): 06/02/2026

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: UU052-30-0200
• Device Catalogue Number: UU052-30-0200
• Device Lot Number: ARC0412602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female