MAUDE Adverse Event Report: PARAGON 28 SCW DRV ATTCH CAN AO HX-6; SCREW, FIXATION, BONE

Catalog Number	P99-190-TX06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in south africa.The product has been received by zimmer biomet, and the investigation is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during a scarf osteotomy for bunion repair, the cannulated screwdriver blade broke during insertion of a screw for metatarsal fixation.During fixation, the surgeon drilled over a k-wire, measured the required screw length, and countersunk the bone.Upon initiating screw insertion in the mid-shaft region of the metatarsal, the cannulated screwdriver blade fractured.There was a brief intra-operative delay of less than 30 seconds while the wire was removed and a solid tx06 screwdriver blade was provided, after which the screw was successfully inserted.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.

• Brand Name: SCW DRV ATTCH CAN AO HX-6
• 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: 25550088
• Report Number: 3008650117-2026-00313
• Device Sequence Number: 10746732
• Product Code: HWC
• UDI-Device Identifier: 00889795052070
• UDI-Public: (01)00889795052070(10)TC2205853
• 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): 06/11/2026

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-TX06
• Device Lot Number: TC2205853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/18/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female