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	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in south africa.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that, during an ankle open reduction and internal fixation procedure, a driver tip fractured at the star interface while tightening 4.0 mm cannulated medial malleolus screws.The fractured fragment was retrieved, and the procedure was completed using a replacement tip.During intraoperative tightening, the surgeon switched hands due to fatigue and then noticed increased movement of the driver on the screw head prior to the tip fracturing.The fragment was removed without major delay, and a different tip was used to complete screw tightening.No known patient impact or adverse consequence was reported.Attempts have been made and no further information has been provided.

• 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 ; 5745260384
• MDR Report Key: 25690743
• Report Number: 3008650117-2026-00366
• Device Sequence Number: 9444005
• Product Code: HWC
• UDI-Device Identifier: 00889795041234
• UDI-Public: (01)00889795041234(10)TC2306741
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: TC2306741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 46 YR
• Patient Sex: Male