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

Model Number	FLIPCUTTER II, SHORT 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/18/2024, it was reported by a sales representative via (b)(4) that an ar-1204as-100 flipcutter¿ ii broke.This occurred during a tibial drilling during an acl procedure the flipcutter 2 broke leaving the outer sheath and flip in the joint and the inner flipping device and blue tab attached to the drill.Because the flipping mechanism was removed we were able to use a grasper and straighten the flip without any patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/7/2024 additional information was provided by the sales representative who stated that the surgeon who is well versed in flipcutter had one break.In typical drilling fashion he drilled on forward full speed.During tibial drilling during an acl procedure the flipcutter 2 broke leaving the outer sheath and flip in the joint and the inner flipping device and blue tab attached to the drill.Because the flipping mechanism was removed, we were able to use a grasper and straighten the flip without any patient harm.The flipcutter is being washed and plan is to send to arthrex.Attached were 2 photos of the disposable flip cutter and the reference number.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• 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: 20587356
• Report Number: 1220246-2024-08369
• Device Sequence Number: 12404011
• Product Code: HWE
• UDI-Device Identifier: 00888867004283
• UDI-Public: (01)00888867004283(11)240301(17)290228(10)4057139057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/07/2025

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: 4057139057
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 06/11/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/24/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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