MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, SMALL IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, SMALL IMPACTOR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the dovetail feature broke off ad the distal end of the impactor is damaged and deformed.A likely cause of the event is user-applied mechanical forces.
Event or Problem Description
On 11/29/2021, it was reported by a facility representative via e-mail that a ar-613-98 ibalance tka broke.This was discovered on (b)(6) 2021 during a tka when the surgeon was using the small impactor and the metal coupling device broke.The broken fragments were retrieved, and another impactor was used to complete the case.
Additional Manufacturer Narrative
Complaint confirmed, the dovetail feature broke off ad the distal end of the impactor is damaged and deformed.A likely cause of the event is user-applied mechanical forces.
Event or Problem Description
On 11/29/2021, it was reported by a facility representative via e-mail that a ar-613-98 ibalance tka broke.This was discovered on (b)(6) 2021 during a tka when the surgeon was using the small impactor and the metal coupling device broke.The broken fragments were retrieved, and another impactor was used to complete the case.

• Brand Name: IBALANCE TKA, SMALL IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13054933
• Report Number: 1220246-2021-04158
• Device Sequence Number: 17379766
• Product Code: LXH
• UDI-Device Identifier: 00888867116955
• UDI-Public: 00888867116955
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBALANCE TKA, SMALL IMPACTOR
• Device Catalogue Number: AR-613-98
• Device Lot Number: 113601338
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown