MAUDE Adverse Event Report: PARAGON 28 SCW DRV ATCH SD AO HX-10 SHT TPR; SURGICAL SCREWDRIVER, REUSABLE

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	11/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in (b)(6).The customer has indicated that the product is in process of being evaluated.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the screwdriver tip broke off during the case.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: SURGICAL SCREWDRIVER, REUSABLE
• 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: 24182466
• Report Number: 3008650117-2026-00022
• Device Sequence Number: 21203836
• Product Code: HWC
• UDI-Device Identifier: 00889795041326
• UDI-Public: (01)00889795041326(10)TC26570
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K190365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: TC26570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown