MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE UKA, FEMORAL TRIAL, SZ 5, LM/RL; TEMPLATE FOR CLINICAL USE

Model Number	AR-601-FTLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2020
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 a (b)(6) 2020 medial uka procedure the surgeon was removing the arthrex ar-601-ftle, ibalance uka trial femoral implant (lot unknown).The surgeon was using a small curved osteotome to remove the trial implant and as he gently tapped the topside of the trial to disengage it from the distal femur, it came off at an angle in which the inside portion of the medial condyle came off with it.The ar-601-ftle trial implant did not break and the instrument the surgeon was using to remove the trial also did not break.The surgeon did complete the procedure as intended after evaluating that there was enough distal femur left for decent fixation.He finished the procedure cementing the permanent femoral component as intended.Since there was no issue with the arthrex ar-601-ftle itself the device will not be returned for evaluation.

• Brand Name: IBALANCE UKA, FEMORAL TRIAL, SZ 5, LM/RL
• Common Device Name: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11075935
• Report Number: 1220246-2020-02430
• Device Sequence Number: 3206499
• Product Code: HWT
• UDI-Device Identifier: 00888867037151
• UDI-Public: 00888867037151
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 12/28/2020

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 Model Number: AR-601-FTLE
• Device Catalogue Number: AR-601-FTLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other