MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA TIBIAL IMPACTOR, SOLID HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBAL TKA TIBIAL IMPACTOR, SOLID HANDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
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 10/12/2022, it was reported by a sales representative via sems that a ar-623-36 tibial impactor broke.This occurred during a total knee arthroplasty procedure when the device broke, there was no patient effect reported.No additional information provided.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation of the device shows the tibial impactor head split in half.Split occurred in the middle of the part, in the cavity that surrounds the shaft pin.The strike cap appears heavily used with dents and marks.The handle also shows signs of wear.The observed condition is attributed to undetermined.

• Brand Name: IBAL TKA TIBIAL IMPACTOR, SOLID HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15698212
• Report Number: 1220246-2022-05671
• Device Sequence Number: 14803017
• Product Code: LXH
• UDI-Device Identifier: 00888867229938
• UDI-Public: 00888867229938
• 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): 01/04/2023

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 TIBIAL IMPACTOR, SOLID HANDLE
• Device Catalogue Number: AR-623-36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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