MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 9.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 9.5MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via sems that an ar-1204as-95 was being used during a procedure.The surgeon drilled the tibia and once in the joint, deployed the flipcutter.He pulled back slowly and the blade broke off in the joint.A grasper was used to remove the broken piece and an ar-1204ff was opened and used to complete the tibia tunnel drilling with no adverse effect to the patient.Additional information requested.
Event or Problem Description
On 12/20/2021, it was reported by a sales representative via sems that an ar-1204as-95 was being used during a procedure.The surgeon drilled the tibia and once in the joint, deployed the flipcutter.He pulled back slowly and the blade broke off in the joint.A grasper was used to remove the broken piece and an ar-1204ff was opened and used to complete the tibia tunnel drilling with no adverse effect to the patient.Additional information requested.

• Brand Name: FLIPCUTTER II, SHORT 9.5MM
• 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: 13167476
• Report Number: 1220246-2022-04249
• Device Sequence Number: 4206968
• Product Code: HWE
• UDI-Device Identifier: 00888867004443
• UDI-Public: 00888867004443
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 01/05/2022

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 Expiration Date: 05/31/2026
• Device Model Number: FLIPCUTTER II, SHORT 9.5MM
• Device Catalogue Number: AR-1204AS-95
• Device Lot Number: 1144112630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/05/2022
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown