MAUDE Adverse Event Report: ARTHREX, INC. 11.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	11.0 MM FLIP CUTTER II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon had three flipcutter ii disintegrate in the knee as drilling femoral tunnel.The first time they started drilling with blade on bone and the rep instructed them to start the drilling at full speed before pulling back onto the bone.But the same thing happened on the second and the third time.The patient was a 17 year old male.On all three occasions, the metal pieces of the device broke off and needed to be retrieved by the surgeon.
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
The complaint is confirmed based on the customer provided photo, which displays the damage of the cutter tip.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: 11.0 MM FLIP CUTTER II
• 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: 15445979
• Report Number: 1220246-2022-05513
• Device Sequence Number: 7522365
• Product Code: HWE
• UDI-Device Identifier: 00888867004139
• UDI-Public: 00888867004139
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 03/08/2023

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: 11.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-110
• Device Lot Number: 811082732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 03/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown