MAUDE Adverse Event Report: Paragon 28 SCW DRIVER ATTCH CAN AO TX-10; Screw, Fixation, Bone

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	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screwdriver broke intra-operatively during an orif ankle procedure.The procedure was completed using a secondary screwdriver available as backup, and no fragments or components fell into the patient.There were no consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H4: multiple manufacture dates were listed in the dhr documents: (b)(6)2017.(b)(6)2017.(b)(6)2018.G2: foreign - event occurred in singapore.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified the driver tip is broken off.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCW DRIVER ATTCH CAN AO TX-10
• 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 ; +1(574)526-0384
• MDR Report Key: 50752571
• Report Number: 3008650117-2026-00504
• Device Sequence Number: 21181097
• Product Code: HWC
• UDI-Device Identifier: 00889795041234
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: Exempt
• 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): 09/14/2026

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: TC27328
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2026
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown