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	Foreign Body In Patient (2687)
Date of Event	07/29/2025
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 07/29/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1204as-95 flipcutter tip of the device broke off during the surgery, and fragments fell into the patient.The surgeon was unable to remove all of the fragments, and some remain inside the patient.The surgery was completed using a new product in a different size.The patient's bone quality is reported to be hard.No revision surgery is currently planned.This occurred during use in an acl reconstruction surgery case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1204as-95 batch 3261135006 was received for evaluation.Visual inspection revealed that the tip of the device had broken off from the shaft.Evaluation of the received pieces confirmed that the pieces are fragments of the tip.It was not damaged and had no dents on the small fragments or the pieces attached to the tip, indicating possible contact with another instrument or excessive force.The most likely cause of the reported and observed failure is a user error.Including excessive force, misalignment of the insertion, and possible contact with another instrument during use.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22797431
• Report Number: 1220246-2025-03482
• Device Sequence Number: 8264975
• Product Code: HWE
• UDI-Device Identifier: 00888867004443
• UDI-Public: 00888867004443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/05/2025

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: 3261135006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown