MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE; DRILL BIT

Model Number	DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a talonavicular fusion surgery the device broke during surgery.The broken part was left inside the patient.Per complaint reporter there was no other harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.Update 5-mar-26: more information was provided that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE
• Common Device Name: DRILL BIT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24619547
• Report Number: 1220246-2026-01468
• Device Sequence Number: 9586290
• Product Code: HTW
• UDI-Device Identifier: 00888867326187
• UDI-Public: (01)00888867326187(11)210414(10)032115
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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 Model Number: DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE
• Device Catalogue Number: AR-8717D-03-RU
• Device Lot Number: 032115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown