MAUDE Adverse Event Report: ARTHREX, INC. 3.8X130MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.8X130MM FIBULA NAIL, LEFT
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/1/2022, it was reported by a sales representative via email that an ar-8973l-38-130 fibulock nail talons appeared to be slightly deployed upon opening package.During insertion, the talons would not fully deploy nor retract, therefore, surgeon removed it completely and used a new fibulock nail to finish the case.This was discovered during a procedure on (b)(6) 2022.Additional information received on 6/1/2022: this was discovered during an ankle fracture procedure.
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.Upon visual inspection, it was noted that the talons were partially deployed.As the device was received unpacked, the as-received condition cannot be confirmed.The most likely cause for the reported failure can be attributed to a manufacturing issue.Due to the unpackaged state of the device, the as received condition cannot be verified.

• Brand Name: 3.8X130MM 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: 19163941
• Report Number: 1220246-2024-02245
• Device Sequence Number: 7855543
• Product Code: HSB
• UDI-Device Identifier: 00888867295247
• UDI-Public: 00888867295247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• 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): 04/23/2024

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: 3.8X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-38-130
• Device Lot Number: 14790006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown