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

Model Number	FLIPCUTTER II, SHORT 9MM
Medical Device Problem Codes	Use of Device Problem (1670); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
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 an anterior cruciate ligament all inside reconstruction the flip cutter failed to flip back from 9mm to 3.5mm.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.The femoral tunnel was reamed through the first cortex and an extender button was used to finish the surgery successfully.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection revealed that the distal cutter tip of the returned flipcutter¿ ii, short 9.0 mm, was stuck, twisted, and had chipped edges.The distal end of the shaft showed that the slots were twisted.Functional testing revealed that the cutter tip was stuck between the slots on the distal end of the shaft.The method used to prepare the bone, as well as the bone quality encountered, were not provided.The most likely cause for the reported failure can be attributed to user error due to improper bone prep; misaligned insertion; and prying/leveraging the device during insertion.

• 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: 18621673
• Report Number: 1220246-2024-00658
• Device Sequence Number: 2406386
• 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,Followup
• Report Date (Section B): 07/30/2024

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: 3152132154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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