MAUDE Adverse Event Report: Arthrex, Inc. QUAD TENDON STRIPPER- CUTTER; MANUAL INSTR, GENERAL SURGICAL

Model Number	QUAD TENDON STRIPPER- CUTTER
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• Brand Name: QUAD TENDON STRIPPER- CUTTER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 50277344
• Report Number: 1220246-2026-04352
• Device Sequence Number: 15921166
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: (01)00888867098244(11)251211(10)3403661010
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 09/16/2026

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: QUAD TENDON STRIPPER- CUTTER
• Device Catalogue Number: AR-2384
• Device Lot Number: 3403661010
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown