MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.Evaluation of the pictures attached to the complaint of an alleged ar-1204as-90 flipcutter ii short 9mm complaint.It is concluded that the actuator tube was detached from the hub at the weld to the adapter tube.It was not possible to determine damage to the tip.The most likely cause for the reported failure can be attributed to misaligned insertion prying/leveraging the device during insertion.
Event or Problem Description
It was reported that during an anterior cruciate ligament all-inside surgery the outer shell of flipcutter broke.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique.A second surgery was required.Update avoe 04-jan-2024 it was confirmed that no second surgery was required and the device broke during surgery.

• Brand Name: FLIPCUTTER II, SHORT 9MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18582256
• Report Number: 1220246-2024-00548
• Device Sequence Number: 8517716
• Product Code: HWE
• UDI-Device Identifier: 00888867004436
• UDI-Public: 00888867004436
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/25/2024

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 9MM
• Device Catalogue Number: AR-1204AS-90
• Device Lot Number: 2313126773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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