MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.0X130MM FIBULA NAIL, LEFT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/15/2022, it was reported by a arthrex employee via email that an ar-8973l-30-130 fibulock nail talons did not fully deploy.Surgeon removed the 1.6 guidewire and insert the left fibulock nail with the out trigger directly lateral to the leg.Before the talons are activated, surgeon placed a 1.6mm k-wire to confirm the nail position on fluoroscopy.The nail was flushed in the fibula.Then, surgeon remove the impactor cap and insert the actuation driver, held the out trigger and turn the actuation driver to deploy the talons.Only two click sounds were heard and there were more sound.The talons did not deploy fully.Surgeon checked with fluoroscopy and the deployment of talons was not significant.Surgeon could not remove the nail.The nail is intact inside the patient fibula.Surgeon used two 2.7mm screws to complete the case.This was discovered during a left ankle nailing with fibulock procedure.No further issues has been reported.
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 nail did not deploy.It was reported that the device was left in the patient and the surgery was completed successfully.Additionally, without the return of the device, further investigation cannot be performed.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: 3.0X130MM 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: 19400027
• Report Number: 1220246-2024-03976
• Device Sequence Number: 12875712
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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: 11/30/2025
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 12350059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2020
• 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