MAUDE Adverse Event Report: ARTHREX, INC. 8.0 MM FLIP CUTTER II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	8.0 MM FLIP CUTTER II
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during an all inside acl repair surgery the arthrex flipcutter ar-1204af-80 was used.The flipcutter worked well during the femoral drilling.But the device failed while the surgeon was drilling the tibial tunnel.The surgeon had drilled five times, a 0.5cm socket in the tibia, when the cutting blade shattered.The surgeon retrieved some of the broken fragments but it was not possible to retrieve the last piece.It will remain inside the patient.The surgery was completed successfully with a new device of the same part number.There was no change of the surgical technique and also no second surgery necessary.
Additional Manufacturer Narrative
Complaint confirmed, the distal end of the device was found to be broken and the cutter tip detached.The cutter tip was not returned for evaluation.Complainant's event is most likely caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces applied during use.

• Brand Name: 8.0 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
• MDR Report Key: 9353310
• Report Number: 1220246-2019-01427
• Device Sequence Number: 16705007
• Product Code: HWE
• UDI-Device Identifier: 00888867004245
• UDI-Public: 00888867004245
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 8.0 MM FLIP CUTTER II
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 602962043
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other