MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 11MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 11MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while retrograde drilling during an all-inside anterior cruciate ligament surgery the shaft broke and the cutter came loose.The broken-off piece could be removed by doing a complete tibial socket, as result, it was necessary to implant a larger button.There was no harm to the patient, operator, or third party.The surgery was finished successfully with an 11mm drill.It was not necessary to do a second surgery.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Functional testing was not performed due to condition of the device.Visual evaluation revealed that the cutter tip of the device is stuck and the actuator tube broke off.Probable cause is attributed to misuse due to applying excessive forces to the device.Refer to investigation photos.

• Brand Name: FLIPCUTTER II, SHORT 11MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 16618226
• Report Number: 1220246-2023-06493
• Device Sequence Number: 17623214
• Product Code: HWE
• UDI-Device Identifier: 00888867004306
• UDI-Public: 00888867004306
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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 11MM
• Device Catalogue Number: AR-1204AS-110
• Device Lot Number: 2228124421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown