MAUDE Adverse Event Report: Paragon 28 Gorilla Plating System MTP, 0 degree, Medium Plate, Left; Plate, Fixation, Bone

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an mtp plate broke in half, revision surgery took place approximately 15 months post implantation due to patient experiencing pain ¿ existing hardware removed.Used p28 hardware used to complete revision.Screws are fine.Patient was not involved in any car accident, slip trip or fall but patient did have a non-union.The plate broke at the joint.Attempts have been made and not available information has been provided.
Additional Manufacturer Narrative
(b)(4) complaint was confirmed.Visual evaluation was completed and found that the device was fractured.The device was submitted for further analysis.Fracture analysis has been previously analyzed on a zrm document where fast-brittle type tensile/bending overload was identified as the mode of failure.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: Gorilla Plating System MTP, 0 degree, Medium Plate, Left
• Common Device Name: Plate, 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 ; +1(574)526-0384
• MDR Report Key: 50086184
• Report Number: 3008650117-2026-00446
• Device Sequence Number: 10271469
• Product Code: HRS
• UDI-Device Identifier: 00889795009272
• UDI-Public: (01)00889795009272(10)JP1806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: P53-103-L002
• Device Lot Number: JP1806
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 246 LB