MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION; SELF DRILLING VARIABLE SCREW, GOLD, 4.0X16MM

Model Number	UM150-40-16
Medical Device Problem Codes	Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was not able to insert self-drilling screws.Report 4 of 5.

• Brand Name: UNION
• Common Device Name: SELF DRILLING VARIABLE SCREW, GOLD, 4.0X16MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• Manufacturer (Section G): ARCAMED LLC; 5101 decatur blvd.; suite a; indianapolis IN 46241
• Manufacturer Contact: louis milos ; 18221 edison ave.; chesterfield, MO 63005
• MDR Report Key: 13045978
• Report Number: 3005823819-2021-00036
• Device Sequence Number: 5436716
• Product Code: KWQ
• UDI-Device Identifier: 00814386020954
• UDI-Public: 00814386020954
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150666
• 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): 12/20/2021

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: UM150-40-16
• Device Catalogue Number: UM150-40-16
• Device Lot Number: ARC03297B02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization
• Patient Sex: Unknown