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

Model Number	FLIPCUTTER II, SHORT 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a cruciate ligament reconstruction surgery the blade of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.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-dec-2023 it was confirmed that the tip of the device broke off in the patient's joint and was then removed.
Additional Manufacturer Narrative
One unpackaged ar-1204as-80 batch number 2269125448 was received for evaluation.Visual inspection found that the instrument was received disassembled due to the damage.The outer/actuator tube was detached from the purple handle at the proximal end of the weld.No cutter shaft legs or blades are attached to the tube tip.It was observed that the outside diameter of the outer tube was bent at the proximal end.It is not possible to do a functional test due to the damage to the device.A user error is the most likely cause for the reported and observed failure.Mechanical damage to the device, such as hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18466848
• Report Number: 1220246-2024-00198
• Device Sequence Number: 16919242
• Product Code: HWE
• UDI-Device Identifier: 00888867004412
• UDI-Public: 00888867004412
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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 8MM
• Device Catalogue Number: AR-1204AS-80
• Device Lot Number: 2269125448
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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