MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA LOCK FEM IMPACT, REPLACE BUMPER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	IBAL TKA LOCK FEM IMPACT, REPLACE BUMPER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
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-613-49rb replacement bumpers poly portion of the instrument snapped off.This occurred on (b)(6) 2022 during a revers.The case was completed.There was no additional information provided.Additional information requested.

• Brand Name: IBAL TKA LOCK FEM IMPACT, REPLACE BUMPER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 15445950
• Report Number: 1220246-2022-05509
• Device Sequence Number: 20710752
• Product Code: HWE
• UDI-Device Identifier: 00888867284371
• UDI-Public: 00888867284371
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 09/19/2022

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 LOCK FEM IMPACT, REPLACE BUMPER
• Device Catalogue Number: AR-613-49RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown