MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIB BRNG TRL CR + SZ 1,9MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL TKA TIB BRNG TRL CR + SZ 1,9MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
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 (b)(6) 2022, it was reported by a sales representative via sems that an ar-603-a109 trial inserter broke in half when being removed from inside the patient.Surgeon went a size up and was able to complete the case without further issues.This was discovered during a tka procedure and nothing broke inside the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-603-a109 was received for investigation.Visual inspection identified that the trial had split into two pieces, with surface damage noted along the remainder of the trial body.The cause remains undetermined, although a probable cause is attributed to damage incurred during the removal process.It was also identified that the batch associated with the reusable device had been manufactured in 2015.

• Brand Name: IBAL TKA TIB BRNG TRL CR + SZ 1,9MM
• Common Device Name: TEMPLATE FOR CLINICAL USE
• 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: 13569767
• Report Number: 1220246-2022-04500
• Device Sequence Number: 2569821
• Product Code: HWT
• UDI-Device Identifier: 00888867112384
• UDI-Public: 00888867112384
• 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,Followup
• Report Date (Section B): 06/30/2022

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: IBAL TKA TIB BRNG TRL CR + SZ 1,9MM
• Device Catalogue Number: AR-603-A109
• Device Lot Number: 113601541
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown