MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, TROCAR PIN SMOOTH; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	IBALANCE TKA, TROCAR PIN SMOOTH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the ar-613-50 was stuck inside the ar-611-trlm.Metal burrs were seen around the pin hole.The pin tip is flattened and the hex feature is twisted and broken.A likely cause of the device getting stuck and hex feature breaking is prying/leveraging the pin during use.
Event or Problem Description
It was reported during a partial knee replacement a smooth guide pin cold welded into the ar-611-trlm left tibial cutting guide.The surgeon was able to complete the cut with a single pin in place and holding the guide in place.During the procedure a small piece of the ar-601-tbe8 8mm trial broke off.The rep reported the piece was easily retrieved, but thrown out.See source data and image.Additional information received on 1/25/21: the trial poly broke while inserting it for trial.It broke into two distinct pieces while trialing it in the knee.The smaller piece that broke off fell onto the or table and was discarded after assessing that the two pieces accounted for the entire trial component and there was no missing piece.There were no unplanned incisions.The case was completed without difficulty, as the remaining trial component was adequate to trial and the decision for the final implantable component was made.Additional information obtained on 2/4/21: the complaint product (ar-601-tbe8 and ar-611-trlm) was returned for evaluation.The defective pin ar-613-50 (lot: 011950) was returned stuck within the guide.Upon investigation it was noted that ar-613-50 is also broken.
Additional Manufacturer Narrative
Complaint confirmed, the ar-613-50 was stuck inside the ar-611-trlm.Metal burrs were seen around the pin hole.The pin tip is flattened and the hex feature is twisted and broken.A likely cause of the device getting stuck and hex feature breaking is prying/leveraging the pin during use.

• Brand Name: IBALANCE TKA, TROCAR PIN SMOOTH
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11358089
• Report Number: 1220246-2021-02611
• Device Sequence Number: 13744811
• Product Code: MDM
• UDI-Device Identifier: 00888867116542
• UDI-Public: 00888867116542
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 02/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBALANCE TKA, TROCAR PIN SMOOTH
• Device Catalogue Number: AR-613-50
• Device Lot Number: 011950
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1