MAUDE Adverse Event Report: ARTHREX, INC. DOUBLE COMPRESSION PLATE SET; MANUAL INSTR, GENERAL SURGICAL

Model Number	DOUBLE COMPRESSION PLATE SET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
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 12-mar-2026, arthrex was notified via email of a case study published in 2021 by foot & ankle orthopaedics, titled ¿radiographic outcomes, union rates, and complications associated with plantar implant positioning for midfoot arthrodesis".The study reviewed thirty-four (34) patients who underwent midfoot arthrodesis, using ar-8006s ¿ double compression plate set.During the sixteen to sixty-six (16-66) month follow-up period, four (4) patients experienced plate breakage without nonunion.Source: fraser tw, miles dt, huang n, davis fb, dunlap bd, doty jf.Radiographic outcomes, union rates, and complications associated with plantar implant positioning for midfoot arthrodesis.Foot & ankle orthopaedics.2021/07/01 2021;6(3):24730114211027115.Doi:10.1177/24730114211027115.

• Brand Name: DOUBLE COMPRESSION PLATE SET
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24800217
• Report Number: 1220246-2026-01991
• Device Sequence Number: 10678681
• Product Code: LXH
• UDI-Device Identifier: 00888867121799
• UDI-Public: 00888867121799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: DOUBLE COMPRESSION PLATE SET
• Device Catalogue Number: AR-8006S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown