MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 11X10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 11X10L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6)2024, it was reported by a sales representative via email that the 2.6 mm drill bit from an ar-9928bck-mis fibertak achilles speedbridge kit broke when going over the wire drilling for the distal tunnel with the red guide.The drill bit broke into many fragments which were all successfully removed.This was discovered during a mis achilles procedure on (b)(6)2024.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/27/2024 additional information was received by a sales representative via email who stated that the procedure performed was an akin osteotomy.An arthrex representative was present.The patient's bone quality was very good.Another staple 9x7 was used to complete the procedure.The procedure was delayed by 10 minutes.No need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the visual evaluation information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 11X10L
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 20192993
• Report Number: 1220246-2024-07526
• Device Sequence Number: 20501813
• Product Code: JDR
• UDI-Device Identifier: 00888867288065
• UDI-Public: 00888867288065
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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 NITI STAPLE W/INSTRS 11X10L
• Device Catalogue Number: AR-8717DS-1110
• Device Lot Number: 2206123791
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 06/09/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/20/2024; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown