MAUDE Adverse Event Report: Paragon 28 SCW DRIVER ATTCH CAN AO TX-10; Screw, Fixation, Bone

Catalog Number	P99-190-TT10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the driver tip broke during surgery.The surgery was successfully completed with another driver, and all debris was removed with no report of injury.
Additional Manufacturer Narrative
(b)(4) the device is pending returned for analysis.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: SCW DRIVER ATTCH CAN AO TX-10
• Common Device Name: Screw, Fixation, Bone
• Manufacturer (Section D): Paragon 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer (Section G): Paragon 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50194913
• Report Number: 3008650117-2026-00463
• Device Sequence Number: 13264154
• Product Code: HWC
• UDI-Device Identifier: 00889795041234
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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 Catalogue Number: P99-190-TT10
• Device Lot Number: TC2208325
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/21/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Male