MAUDE Adverse Event Report: Arthrex, Inc. SuperMX Compression Staple, 20W x 20L; STAPLE, FIXATION, BONE

Model Number	SuperMX Compression Staple, 20W x 20L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 22nd july 2026, arthrex became aware of a published case report " incidence and associated factors of 2-legged nitinol staple breakage in foot and ankle surgery".The ar-8719mx-2020, dynanite® supermx nitinol staple, 20w x 20l, was used during an ankle arthrodesis procedure on (b)(6) 2023.Postoperatively, breakage of the device in vivo and the development of a symptomatic non-union were observed.Although the exact timing of the revision surgery could not be confirmed, a procedure involving sliding bone grafting, autologous iliac bone grafting, and fixation with cannulated compression screws (ccs) was subsequently performed.The patient's postoperative course was favorable.The physician determined that there was no direct causal link between the staple breakage and the formation of the non-union; therefore, the incident was not considered to constitute harm to the patient's health resulting from product quality issues.This case was identified internally by arthrex through the attached academic literature, and a sales representative subsequently interviewed the physician.Source citation: ikuta y, nakasa t, ishibashi s, et al.Incidence and associated factors of 2-legged nitinol staple breakage in foot and ankle surgery.Foot & ankle international.2026;0(0).Doi:10.1177/10711007261462533.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SuperMX Compression Staple, 20W x 20L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50176750
• Report Number: 1220246-2026-04242
• Device Sequence Number: 15924503
• Product Code: JDR
• UDI-Device Identifier: 00888867300965
• UDI-Public: (01)00888867300965(11)230101(17)271231(10)2265125358
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SuperMX Compression Staple, 20W x 20L
• Device Catalogue Number: AR-8719MX-2020
• Device Lot Number: 2265125358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown