MAUDE Adverse Event Report: PARAGON 28 SCW DRV ATCH SD AO HX-10 SHT TPR; SCREW, FIXATION, BONE

Catalog Number	P99-191-TR10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in south africa.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 a primary metatarsophalangeal (mtp) arthrodesis, a screwdriver tip fractured during the final tightening of a locking screw.As the final step of the procedure, when tightening the last screw in the plate, the driver tip broke.The screwdriver was replaced, and during final tightening of the same screw, the replacement driver tip also fractured.No known impact or consequence to the patient.Attempts have been made and no further information has been provided.

• Brand Name: SCW DRV ATCH SD AO HX-10 SHT TPR
• 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 ; 5745260384
• MDR Report Key: 25033933
• Report Number: 3008650117-2026-00200
• Device Sequence Number: 9039887
• Product Code: HWC
• UDI-Device Identifier: 00889795041326
• UDI-Public: (01)00889795041326(10)TC2206300
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: NI
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: P99-191-TR10
• Device Lot Number: TC2206300
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 64 YR
• Patient Sex: Male