MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE UKA TIBIAL IMP- ACTOR BODY ASSY; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE UKA TIBIAL IMP- ACTOR BODY ASSY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
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 8/28/2023, it was reported by a sales representative via sems-06016486 that an ar-601-tib0 ibalance uka, tibial impactor body assembly, and an ar-601-tih0 ibalance uka, tibial impactor head broke in a case.There was no issue with the patient.This occurred during use in an unspecified procedure on (b)(6) 2023 with no patient harm.Additional information has been requested.On 9/15/2023, the sales representative provided the following information via email: this occurred during a reverse procedure, it was not a revision surgery.The devices broke inside the patient, and all fragments were retrieved.A competitor's product was used to complete the case successfully, and there was no adverse effect to the patient or a case delay reported.The bone quality of the patient was not provided.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: IBALANCE UKA TIBIAL IMP- ACTOR BODY ASSY
• 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: 17817227
• Report Number: 1220246-2023-07978
• Device Sequence Number: 19408776
• Product Code: LXH
• UDI-Device Identifier: 00888867037847
• UDI-Public: 00888867037847
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/25/2024

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: IBALANCE UKA TIBIAL IMP- ACTOR BODY ASSY
• Device Catalogue Number: AR-601-TIB0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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