MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 5 8MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL UKA TIB BEA-RING TRL SZ 5 8MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
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 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.Additional information received on 1/25/2021: 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 Manufacturer Narrative
Complaint confirmed, the trial was found to be broken and dented.The cause of the event is undetermined, however a likely cause of the event is user-applied mechanical forces.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 5 8MM
• Common Device Name: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11275721
• Report Number: 1220246-2021-02545
• Device Sequence Number: 1166885
• Product Code: HWT
• UDI-Device Identifier: 00888867037687
• UDI-Public: 00888867037687
• 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): 02/05/2021

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: IBAL UKA TIB BEA-RING TRL SZ 5 8MM
• Device Catalogue Number: AR-601-TBE8
• Device Lot Number: 6791420
• 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: 02/03/2021
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other