MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,TIB BEARING TRL SZ 5, 9MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL TKA,TIB BEARING TRL SZ 5, 9MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/10/2022, it was reported by a sales representative via sems that a ar-623-t509 ibalance® tka broke.This occurred during a case, the broken item was removed and the case went on without issue.There was no harm to the patient.Additional information requested.
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
The complaint was confirmed.Picture evaluation of an ar-623-t509 balance® tka, tibial bearing trial size 5 (9 mm thickness), batch 132581530 attached to the complaint.It is concluded that the device was broken into two pieces.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.Per dfu-0023-eor3.I.Cautions.2.To avoid damaging the instrument, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.6.Flexion of the joint with the instrument in position in the joint may result in vending or breakage of the instrument.

• Brand Name: IBAL TKA,TIB BEARING TRL SZ 5, 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: 15893065
• Report Number: 1220246-2022-05826
• Device Sequence Number: 6707813
• Product Code: HWT
• UDI-Device Identifier: 00888867215191
• UDI-Public: 00888867215191
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/19/2023

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 BEARING TRL SZ 5, 9MM
• Device Catalogue Number: AR-623-T509
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown