MAUDE Adverse Event Report: ARTHREX, INC. 3.0X180MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.0X180MM FIBULA NAIL, LEFT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2021
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.Complaint confirmed.Visual evaluation identified that the fibulock nail itself did not contain rust or discoloration on the device.The pu sleeve was found to contain the discoloration around the weld points.An ncr was initiated to further investigate the event.
Event or Problem Description
On 11/15/2021, it was reported by a facility representative via e-mail that a ar-8973l-30-180 fibulock nail inner packaging may be rusted.This was discovered during a case when one of the sales representatives opened the box to the fibulock nail and it was found to have some sort of substance or rust inside.There was no patient effect reported.

• Brand Name: 3.0X180MM FIBULA NAIL, LEFT
• 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: 19214633
• Report Number: 1220246-2024-02633
• Device Sequence Number: 6960896
• Product Code: HSB
• UDI-Device Identifier: 00888867295223
• UDI-Public: 00888867295223
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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 Expiration Date: 09/30/2026
• Device Model Number: 3.0X180MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-180
• Device Lot Number: 14279042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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