MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 6MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 6MM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
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
On (b)(6) 2023, it was reported by an arthrex employee via sems that an ar-1204as-60 flipcutter ii had an issue.The fixation of the blade was not stable after flipping.The case was completed using a new product.This was discovered during an unspecified procedure on (b)(6) 2023, with no patient harm.Additional information was received on (b)(6) 2023: this was discovered during an acl repair procedure with no reported delay in the case.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual investigation, no problem was found with the device.Functional testing it was noted that the cutter tip actuates as required.No problem found.

• Brand Name: FLIPCUTTER II, SHORT 6MM
• 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: 17559371
• Report Number: 1220246-2023-07512
• Device Sequence Number: 11981848
• Product Code: HWE
• UDI-Device Identifier: 00888867004375
• UDI-Public: 00888867004375
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/04/2024

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 6MM
• Device Catalogue Number: AR-1204AS-60
• Device Lot Number: 2228124418
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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