MAUDE Adverse Event Report: PARAGON 28 SCW DRV ATTCH CAN MODIFIED TX-8; SURGICAL SCREWDRIVER, REUSABLE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the hx8 cannulated driver tip broke during a planned revision.As no backup device was available an implanted screw was left in place.No patient treatment related to this event was reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The reported event is confirmed.Visual examination of the returned product confirmed that the tip is fractured.Further analysis was not performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCW DRV ATTCH CAN MODIFIED TX-8
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 24257743
• Report Number: 3008650117-2026-00026
• Device Sequence Number: 18136626
• Product Code: HWC
• UDI-Device Identifier: 00889795041227
• UDI-Public: (01)00889795041227(10)TC2307750
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P99-190-TT08
• Device Lot Number: TC2307750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown