MAUDE Adverse Event Report: Paragon 28 Monkey Rings HALF PIN SLF DRLG 5.0X45MM; Schanze Screw, Self Drilling, Ø5.0mm X 45mm, 160mm SHANK LENGTH

Catalog Number	P45-191-5045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that half pin broke while inserting during surgery and its debris is still within the t-handle.The other portion of the half pin is implanted in the patient.The break occurred at the very end of the procedure and caused no delay or harm/impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This mdr is submitted late after remediation efforts and a retrospective review of complaint reportability.The reported event was confirmed via product return.Visual examination confirmed device is fractured.Review of the device history records identified no deviations or anomalies during manufacturing.A probably root cause is excessive torque, although this is not confirmed; root cause is not established.If any further information 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: Monkey Rings HALF PIN SLF DRLG 5.0X45MM
• Common Device Name: Schanze Screw, Self Drilling, Ø5.0mm X 45mm, 160mm SHANK LENGTH
• 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: 50046204
• Report Number: 3008650117-2026-00440
• Device Sequence Number: 9462013
• Product Code: KTT
• UDI-Device Identifier: 00889795115195
• UDI-Public: (01)00889795115195(10)KR2205001
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: P45-191-5045
• Device Lot Number: KR2205001
• 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: 06/13/2023
• Initial Report FDA Received Date: 07/27/2026
• 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: Other
• Patient Sex: Male