MAUDE Adverse Event Report: ARTHREX, INC. AVN DISPOSABLES KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AVN DISPOSABLES KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause of the reported failure is use error.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 03/09/2022, it was reported by a sales representative via sems that an ar-3519h hip avn disposables kit had an issue, deployed early and fell apart during the case.This was discovered during use with no impact to the patient.On 03/09/2022, the sales representative provided the following information via phone: during a hip avn procedure on (b)(6) 2022, the portable arm of the reamer deployed early in the patient and the deployment mechanism broke.The whole reamer with the deployed, stuck portable arm was removed from the patient, and no piece broke off inside the patient.Another reamer was used to complete the procedure successfully with no case delay or impact to the patient.

• Brand Name: AVN DISPOSABLES KIT
• 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: jared engle ; 8009337001
• MDR Report Key: 19481738
• Report Number: 1220246-2024-04927
• Device Sequence Number: 15461334
• Product Code: LXH
• UDI-Device Identifier: 00888867266643
• UDI-Public: 00888867266643
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AVN DISPOSABLES KIT
• Device Catalogue Number: AR-3519H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown