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 distal end of the impactor broke off.The cause is undetermined.
Event or Problem Description
On 10/27/2021, it was reported by a sales representative via sems that (2) ar-613-98 small impactor tips broke during use.This was discovered during a tka procedure on (b)(6) 2021.A third impactor was used to finished case without further issues.

• 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: 12819005
• Report Number: 1220246-2021-03932
• Device Sequence Number: 5449149
• Product Code: LXH
• UDI-Device Identifier: 00888867116955
• UDI-Public: 00888867116955
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/16/2021

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: 113601337
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/16/2021
• 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