MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 8.5MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 8.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
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 all inside anterior cruciate ligament reconstruction surgery the tip of the device broke of whilst reaming the femoral tunnel.The tip could not be retrieved.The surgery was finished successfully with a new device with the same part number.The day after on the (b)(6) 2024 a second look arthroscopy was done with fluoroscopy and the tip appeared to be inside the pcl.It was not possible to retrieve the broken off tip during the second surgery.***update avoe 07-feb-2024 it was further reported that for now the patient will be followed up in 2 weeks with a new series of x-rays to see if the fragment will move.It is uncertain if there are any other consequences.The surgeon concurred with 3 other surgeons and said that if the tip is indeed embedded in the pcl that it will most likely cause no harm or pain.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d8/9, h3, h6: type of investigation, investigation findings, investigation conclusions, g3, and h10.Complaint allegation is confirmed.Visual inspection indicated that the distal cutter tip of the returned flipcutter¿ ii, short 8.5 mm, had broken off.No broken pieces were returned.The distal end of the shaft showed that the slots had twisted.Functional testing was not performed due to the damage to the device.The method used to prepare the bone, as well as the bone quality encountered, were not recorded.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; and prying/leveraging the device during insertion.

• Brand Name: FLIPCUTTER II, SHORT 8.5MM
• 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: 18730886
• Report Number: 1220246-2024-01026
• Device Sequence Number: 15217813
• Product Code: HWE
• UDI-Device Identifier: 00888867004429
• UDI-Public: 00888867004429
• 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): 06/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FLIPCUTTER II, SHORT 8.5MM
• Device Catalogue Number: AR-1204AS-85
• Device Lot Number: 3214133914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown