MAUDE Adverse Event Report: Arthrex, Inc. PEEK, Meniscal Root Repair Kit; NON-DEGRADABLE FIXATN FASTENER

Model Number	PEEK, Meniscal Root Repair Kit
Medical Device Problem Codes	Overheating of Device (1437); Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the flipcutter from the meniscal root repair set ar-4550 was extremely dull and became so hot that the bone "burned".Only with extreme pressure did the surgeon then get through and slipped posteriorly into the soft tissue.No further information received.Update 15-sep-2026: further information was provided that the affected device is the ar-4550p, lot: 15491378.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: PEEK, Meniscal Root Repair Kit
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 50817659
• Report Number: 1220246-2026-04803
• Device Sequence Number: 15992039
• Product Code: MBI
• UDI-Device Identifier: 00888867307544
• UDI-Public: (01)00888867307544(11)250902(17)300630(10)15491378
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: PEEK, Meniscal Root Repair Kit
• Device Catalogue Number: AR-4550P
• Device Lot Number: 15491378
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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