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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2023
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
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-1204af-100 flip cutter ii had an issue.During an acl reconstruction procedure on (b)(6) 2023, the surgeon used an ar-1204af-100 flip cutter ii with an unknown lot number and completed the case successfully.A couple of weeks after the surgery, the patient had a follow-up appointment, x-rays were taken, and a fragment of the flip cutter ii was detected inside the patient's knee.On (b)(6) 2023, revision surgery was performed by the same surgeon.The fragment of the ar-1204af-100 flip cutter ii was removed successfully without having to perform a reconstruction surgery, the acl procedural outcome was not impacted by the fragment removal.To date, the patient is fine.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1204af-100 was received for investigation - only the rafc 3.5mm cutter tip was returned for evaluation.Along with one of the cutter tip's pins.Upon visual inspection, it was noted that one of the pins of the cutter tips was missing.The most likely cause for the reported failure can be attributed to misuse due to prying/leveraging forces being applied to the device.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17152381
• Report Number: 1220246-2023-06914
• Device Sequence Number: 20254803
• Product Code: HWE
• UDI-Device Identifier: 00888867004115
• UDI-Public: 00888867004115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 10.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-100
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown