MAUDE Adverse Event Report: ARTHREX, INC. KEEL PUNCH, SIZE 4-7, IBALANCE TKA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	KEEL PUNCH, SIZE 4-7, IBALANCE TKA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a facility representative via sems that an ar-623-t6 tibial prep tray and an ar-623-6 keel punch are broken.This was discovered during a procedure on (b)(6) 2021.
Additional Manufacturer Narrative
Complaint confirmed, the dovetail feature is partially broken.Edges of the device are dented and worn.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.

• Brand Name: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• 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: 13841187
• Report Number: 1220246-2022-04641
• Device Sequence Number: 5778972
• Product Code: LXH
• UDI-Device Identifier: 00888867198371
• UDI-Public: 00888867198371
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/21/2022

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: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• Device Catalogue Number: AR-623-6
• Device Lot Number: 20641511
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown