MAUDE Adverse Event Report: Paragon 28 BG N-LKNG SCW 2.5X22MM; Screw, fixation, bone

Catalog Number	P50-153-2522
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a broken non-locking screw(2.5mm) identified during a recent procedure.It caused no injury and the procedure was delayed by less than 30 minutes.The shaft remains inside the patient¿s body, while only the head was retrieved.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.G2: foreign- event occurred in singapore.Half of the device will not be returned as it remains implanted.The other half was returned.Visual examination of the returned product identified the part was broken.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause can not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The reported event is confirmed as product was returned.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: BG N-LKNG SCW 2.5X22MM
• Common Device Name: Screw, 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: 50045732
• Report Number: 3008650117-2026-00437
• Device Sequence Number: 10635774
• Product Code: HWC
• UDI-Device Identifier: 00889795019523
• UDI-Public: (01)00889795019523(10)PA6456/37
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K190365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: P50-153-2522
• Device Lot Number: PA645637
• 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: 09/12/2025
• Initial Report FDA Received Date: 07/27/2026
• 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: Other
• Patient Sex: Unknown