MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; INTRAMED FIXATN ROD AND ACCESS

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
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 most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
On 06/02/2022 it was reported by a sales representative via sems that an ar-8973ds fibulock implant system had an issue.While performing the fibulock procedure on (b)(6)2022, the surgeon had difficulty advancing the 6.2mm reamer over the 1.6mm wire, even while applying force.The reamer was very difficult to advance and eventually made its way to the desired depth.After removing the reamer they noticed the wire was chewed/about to break so they replaced it with the second wire and the case went smoothly.The case was completed successfully.This was discovered during use with no impact to the patient.On 06/07/2022, the sales representative stated the following information via phone: the distal reamer 6.2mm was very difficult to advance into the distal fibula, not spinning very well.It was noticed after reaming, that the guide wire was frayed 5-6 cm up the wire, had a damaged surface, and was about to break, but did not break inside the patient.They removed the wire in one piece and replaced it with the second wire.The case was completed successfully with no impact to the patient, and the patient was fine to date.No further action was requested, the sales representative just wanted to document the complaint.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19249460
• Report Number: 1220246-2024-02827
• Device Sequence Number: 7337195
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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