MAUDE Adverse Event Report: PARAGON 28 TIBIA ARC LT SZ 3 LG 3DP STRL; PROSTHESIS, ANKLE

Catalog Number	P10-100-BL3L-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implantation of a left ankle system, the medial malleolus fractured.Plate and screws were implantation through the tip of the medial malleolus using a c-arm guidance.Fracture was noted as resolved 5 months later.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: p10-250-tll2-s, talus chamfer lt sz 2 tps strl, lot 260f2882105.P10-310-i207-s, x-link vtmn e poly 2x7mm neu strl, lot 26080992403.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: TIBIA ARC LT SZ 3 LG 3DP STRL
• Common Device Name: PROSTHESIS, ANKLE
• 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: 24791369
• Report Number: 3008650117-2026-00131
• Device Sequence Number: 8938570
• Product Code: HSN
• UDI-Device Identifier: 00889795059659
• UDI-Public: (01)00889795059659(17)280828(10)260F2402314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: P10-100-BL3L-S
• Device Lot Number: 260F2402314
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White