MAUDE Adverse Event Report: ARTHREX INC. IBALANCE TKA, FEMORAL SIZER, 0-7 DEG; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-623-63
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the cap weld was broken, causing the rotation pointers to fall off.At this time, the cause of the event is undetermined.
Event or Problem Description
It was reported that during a right total knee arthroplasty procedure, the washer that holds the external rotation adjustment together came off and could not be located.An x-ray (a/p and lateral) was taken and the washer could not be seen.The case was completed and the outcome was not affected.Patient was male.Follow-up investigation: the ar-62-63 lot number is 37621632.The device part initially referred to as a washer has been confirmed to be subpart c13345-01 "cap" as referred to on the device assembly instructions diagram for ar-623-63.

• Brand Name: IBALANCE TKA, FEMORAL SIZER, 0-7 DEG
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7467848
• Report Number: 1220246-2018-00154
• Device Sequence Number: 1274044
• Product Code: MDM
• UDI-Device Identifier: 00888867256651
• UDI-Public: 00888867256651
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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 Catalogue Number: AR-623-63
• Device Lot Number: 37621632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/27/2018
• 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