MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIB BRNG TRL CR + SZ 5,8MM; ORTHOPAEDIC TEMPLATE

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 5,8MM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 4/23/2024, it was reported by a sales representative via (b)(4) that an ar-603-a508 ibal tka tib brng trl cracked in half upon removal of the trial during a case.No other parts were necessary as the trial portion of the case was completed, and no secondary surgery was needed.No additional time was added to the case.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 4/25/2024: this was discovered during a tka procedure on (b)(6) 2024.The device broke inside the patient and all fragments were retrieved without adverse effects on the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-603-a508, batch number 113601321, was received for investigation.Visual evaluation noted that the trial had broken into two pieces.The device had signs of wear: nicks and chipping.Functional testing could not be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to wear and tear and excessive user-applied mechanical forces over time.The manufacturing date is 2013.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 5,8MM
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19353065
• Report Number: 1220246-2024-03536
• Device Sequence Number: 7280359
• Product Code: HWT
• UDI-Device Identifier: 00888867112698
• UDI-Public: 00888867112698
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: IBAL TKA TIB BRNG TRL CR + SZ 5,8MM
• Device Catalogue Number: AR-603-A508
• Device Lot Number: 113601321
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown