MAUDE Adverse Event Report: ARTHREX, INC. 10.0 MM FLIP CUTTER II; MANUAL INSTR, GENERAL SURGICAL

Model Number	10.0 MM FLIP CUTTER II
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
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 surgery after insertion into the tissue, the drilling tip of the retrograde drill fell out.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 18-mar-2024: it was confirmed that all fragments of the device were retrieved from the patient.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was noted that the cutter tip was bent and attached to the shaft.The shaft of the flipcutter® ii, 10 mm was bent.Functional testing was not performed due to the damage to the device.The quality of the bone encountered was not provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Per surgical technique - all inside pcl reconstruction - the side-specific anatomic contour pcl guide is placed over the back of the tibia and is designed to grasp the distal edge of the posterior facet.This position can be visualized and confirmed by feel when pulling back on the guide.The wide, convex guide tip also facilitates correct placement in the coronal plane by settling in between mamillary bodies.When in position, the marking hook will guide the flipcutter to the ideal location and angle for transtibial pclr.Before drilling the flipcutter, make note of the interosseous length as read by the drill sleeve markings where it enters the guide handle.

• Brand Name: 10.0 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: 19014224
• Report Number: 1220246-2024-01761
• Device Sequence Number: 19782345
• Product Code: HWE
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• 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): 08/16/2024

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 Expiration Date: 03/31/2026
• Device Model Number: 10.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-100
• Device Lot Number: 1075110894
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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