MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 8MM
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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
It was reported that during an all-inside anterior cruciate ligament surgery the size indicated on the packaging was 8 but the flip cutter was actually a 9.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 14-may-2025: it was confirmed that the error was detected while working on the patient.There were no effects on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1204as-80 batch 4078139649 was received for evaluation.Visual inspection revealed that the tip cutter size was laser marked as # 9.Multiple scratches were noted.The cause of the reported failure is a supplier manufacturing process issue.According to the bill of materials (bom), drawing c2359 at revision 12, component c2363-05 8mm cutter tip must be assembled into the shaft of an ar-1204as-80 the complaint allegation was confirmed based on the related nonconformance findings.

• Brand Name: FLIPCUTTER II, SHORT 8MM
• 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: 22098288
• Report Number: 1220246-2025-02265
• Device Sequence Number: 7357494
• Product Code: HWE
• UDI-Device Identifier: 00888867004412
• UDI-Public: (01)00888867004412(11)240401(17)290331(10)4078139649
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/28/2025

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 8MM
• Device Catalogue Number: AR-1204AS-80
• Device Lot Number: 4078139649
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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