MAUDE Adverse Event Report: ARTHREX, INC. HIP ARTHRSCPY MSTR DISP KIT W/BLD; SAW BLADE

Model Number	HIP ARTHRSCPY MSTR DISP KIT W/BLD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.
Event or Problem Description
It was reported during a hip arthroscopy procedure the surgeon was using the ar-6526s hip arthroscopy master disposable kit with blades.The surgeon inserted the nitinol wires and placed the needle over top the wires and, while pulling out the instrumentation, the wires would come out as well.The surgeon informed the rep that they believe the nitinol wires are too large for the percaneous needles.The issue with the device did not hinder the case and the procedure was completed as planned without causing harm or injury to the patient.There are no available pictures of the reported issue.

• Brand Name: HIP ARTHRSCPY MSTR DISP KIT W/BLD
• Common Device Name: SAW BLADE
• 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: 19321122
• Report Number: 1220246-2024-03317
• Device Sequence Number: 7659694
• Product Code: GFA
• UDI-Device Identifier: 00888867039865
• UDI-Public: 00888867039865
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: HIP ARTHRSCPY MSTR DISP KIT W/BLD
• Device Catalogue Number: AR-6526S
• Device Lot Number: 10237997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 05/15/2024
• 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
• Patient Sex: Unknown