MAUDE Adverse Event Report: Arthrex, Inc. FLIPCUTTER II, SHORT 9.5MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 9.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 14th august 2026, it was reported by an arthrex employee via email that for an ar-1204as-95, flipcutter¿ ii, short 9.5 mm, the blade tip of a 9.5 mm flipcutter fractured during use.It was believed that the fracture occurred due to the patient's good bone quality and the drill being powered while the blade was in contact with the bone, resulting in concentrated stress at a single point.The fractured blade fragment was retrieved from the patient.This was detected during use in a acl-qt procedure on (b)(6) 2026.The procedure was completed successfully by using a product with the same part number.No significant surgery delay reported.Nothing remains in the patient.No additional anesthesia administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FLIPCUTTER II, SHORT 9.5MM
• 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: 50473406
• Report Number: 1220246-2026-04505
• Device Sequence Number: 10173332
• Product Code: HWE
• UDI-Device Identifier: 00888867004443
• UDI-Public: (01)00888867004443(11)250101(17)291231(10)5006155711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: FLIPCUTTER II, SHORT 9.5MM
• Device Catalogue Number: AR-1204AS-95
• Device Lot Number: 5006155711
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown