MAUDE Adverse Event Report: PARAGON 28 R3FLEX IMPLANT W/INSR SK; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Catalog Number	P82-001-1237-SK
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
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 attempted implant placement utilizing tibial and fibular tunnels, the implant could not be advanced and intra-operative difficulties occurred with the inserter and suture.Following drilling as per the surgical technique, the implant was advanced through the fibular tunnel and the tibial tunnel was sought.After initial resistance, a mallet was used per technique; fluoroscopic imaging showed the implant had not advanced.The surgeon attempted to remove the implant through the fibular tunnel to redrill and verify trajectory but was unable to retrieve it.A subsequent attempt to locate the tibial tunnel was made, and after applying significant force the implant advanced slightly, then the inserter tip detached from the gray handle.When the surgeon lightly tugged the gray handle to deploy the sock, the suture broke and exited through the fibular tunnel which resulted in the sock being retained by the patient.Attempts have been made and no further information has been provided.

• Brand Name: R3FLEX IMPLANT W/INSR SK
• Common Device Name: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• 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: 24276778
• Report Number: 3008650117-2026-00032
• Device Sequence Number: 8318864
• Product Code: MBI
• UDI-Device Identifier: 00889795128140
• UDI-Public: (01)00889795128140(17)300418(10)945898410825
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K240594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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 Catalogue Number: P82-001-1237-SK
• Device Lot Number: 945898410825
• Was Device Available for Evaluation?: No
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/06/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male