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	05/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw driver broke during a procedure.All debris was removed from the patient.The event caused a delay of 5-10 minutes with no consequences or impact to the patient.A different device was utilized to complete the procedure with no additional surgical complications noted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in singapore.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.

• 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: 25337579
• Report Number: 3008650117-2026-00250
• Device Sequence Number: 9986127
• Product Code: HWC
• UDI-Device Identifier: 00889795041326
• UDI-Public: (01)00889795041326(10)TC2206300
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/29/2026
• 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 Sex: Unknown