MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 10MM
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/31/2022, it was reported by a sales representative via sems that a ar-1204as-100 flipcutter is jammed.This occurred during use on 10/24/2022 when the surgeon could not flip the end straight enough to get out of the 3.5 step sleeve, he ended up removing both the sleeve and the flip cutter.There was no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.One unpackaged ar-1204as-100 batch number 2221124251 was received for investigation.Functional testing found that the cutting tip does not extend/retract.Visual evaluation found debris and burrs on the cutting tip.The internal weld between the driver end and inner shaft is likely broken.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: FLIPCUTTER II, SHORT 10MM
• 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: 19493117
• Report Number: 1220246-2024-05135
• Device Sequence Number: 7037223
• Product Code: HWE
• UDI-Device Identifier: 00888867004283
• UDI-Public: 00888867004283
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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 10MM
• Device Catalogue Number: AR-1204AS-100
• Device Lot Number: 2221124251
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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