MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	FLIPCUTTER II, SHORT 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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
It was reported that during an anterior cruciate ligament surgery the cutting tip broke off from the shaft of the device.The surgeon had to use a different device from another manufacturer to retrieve the broken pieces.There was no harm for patient, operator or third party reported.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.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1204as-90 was returned for investigation.The returned device was visually inspected and noted that the shaft was bent and detached from the handle at the weld.The functional test found that the cutter tip didn¿t move when the button was actioned.However, the tip cutter was not detached from the shaft or broken off.The most likely cause for the reported failure is user error.Mechanical damage to device such as hitting the device with another device or object, prying/leveraging or excessive bending forces applied during use.

• Brand Name: FLIPCUTTER II, SHORT 9MM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 17037313
• Report Number: 1220246-2023-06826
• Device Sequence Number: 7012548
• Product Code: HWE
• UDI-Device Identifier: 00888867004436
• UDI-Public: 00888867004436
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/18/2024

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 9MM
• Device Catalogue Number: AR-1204AS-90
• Device Lot Number: 2193123424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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