MAUDE Adverse Event Report: PARAGON 28 SCW DRV ATTCH CAN AO HX-6; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	P99-190-TX06
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in south africa.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.
Event or Problem Description
It was reported that during tightening of a 2 mm cannulated screw, the driver tip fractured and lodged within the screw head.Intra-operatively, the broken tip and associated debris were retrieved from the patient.There were no clinical signs or symptoms as a result of the driver break.There were no unanticipated surgical complications that occurred.There were no contributing conditions related to the event.The procedure was not delayed and was completed with a different device.Attempts have been made and no further information has been provided.

• Brand Name: SCW DRV ATTCH CAN AO HX-6
• 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: 24827879
• Report Number: 3008650117-2026-00154
• Device Sequence Number: 13369629
• Product Code: HWC
• UDI-Device Identifier: 00889795052070
• UDI-Public: (01)00889795052070(10)TC2205853
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: P99-190-TX06
• Device Lot Number: TC2205853
• Was Device Available for Evaluation?: Yes
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/09/2026
• 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: 65 YR
• Patient Sex: Male