MAUDE Adverse Event Report: ARTHREX, INC. 7.5 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	7.5 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
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 arthroscopy plus osteotomy surgery after insertion into the tissue, the drilling tip of the retrograde drill broke off.All fragments were retrieved from the patient.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint allegation is confirmed.Visual inspection indicated that the distal cutter tip of the returned flipcutter® ii, 7.5 mm, had broken off.The distal end of the shaft showed that the slots had twisted and broken-off.Functional testing was not performed due to the damage to the broken cutter and slots.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: 7.5 MM FLIP CUTTER II
• 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: 18839178
• Report Number: 1220246-2024-01304
• Device Sequence Number: 15238987
• Product Code: HWE
• UDI-Device Identifier: 00888867004238
• UDI-Public: 00888867004238
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/10/2024

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: 7.5 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-75
• Device Lot Number: 3068129797
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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