MAUDE Adverse Event Report: PARAGON 28 SCW DRIVER ATTCH CAN AO TX-10; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	P99-190-TT10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in singapore.The product was recently received, and the zimmer biomet investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a surgical screwdriver broke off intra-operatively during a procedure.The screwdriver fractured during use under normal surgical technique of the right surgical side.The procedure was successfully completed without patient consequences, impact, or delay using the same screwdriver.All debris was removed.There were no contributing conditions related to the event.Attempts have been made and no further information has been provided.

• Brand Name: SCW DRIVER ATTCH CAN AO TX-10
• 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: 24618509
• Report Number: 3008650117-2026-00068
• Device Sequence Number: 9585748
• Product Code: HWC
• UDI-Device Identifier: 00889795041234
• UDI-Public: (01)00889795041234(10)TC2003040
• 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): 03/16/2026

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-TT10
• Device Lot Number: TC2003040
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown