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

Model Number	KEEL PUNCH, SIZE 4-7, IBALANCE TKA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/2/2023, it was reported by a sales representative via (b)(4) that an ar-613-1 ibalance tka, handle, modular keel punch, and an ar-623-6 ibalance tka, keel punch, size 4-7 had an issue.The handle and tibial keel punch connection broke off.The case was completed successfully without further information, and no pieces breaking off inside the patient.This was discovered during a total knee arthroplasty procedure on 11/2/2023, with no reported patient harm.Additional information received on 11/7/2023: ar-613-1 ibalance tka, handle, modular keel punch, and an ar-623-6 ibalance tka, keel punch broke off inside the patient with all fragments retrieved from the patient.The metal piece that broke off the keel punch is inside the tka handle.The case was delayed 2 minutes and completed using plyers to get the size 4-7 keel punch out of the patient's tibia.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.Functional testing was not performed on the returned ar-623-6 due to the damage to the device.Visual evaluation noted that the tip on the back of the device that connects to the ar-613-1 handle is broken off.The most likely cause is attributed to misuse due to use error.Refer to the investigation photos.

• Brand Name: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18223255
• Report Number: 1220246-2023-08960
• Device Sequence Number: 14880454
• 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,Followup
• Report Date (Section B): 08/20/2024

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: 37621845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown