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

Model Number	3.0X130MM FIBULA NAIL, RIGHT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2024, it was reported by a facility representative via email that an ar-8973r-30-130 fibulock nail proximal talons on the fibular nail did not deploy when engaged with the actuator.When the surgeon placed the actuator into the nail, it never clicked or connected with the implant but instead just spun in place.The surgeon removed the nail from the fibula to see if it was placed properly on the jig, and if anything was blocking the actuator.The implant was tightly secured, and there was still no engagement.The fibulock nail was removed and another ar-8973r-30-130 fibulock nail was used to complete the case.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8973r-30-130 arthrex fibulock® nail lot number: 15143473 was received for investigation.Visual evaluation noted no problems with the device.Further visual inspection under a magnifier noted no problems with the hex of the retention screw.Functional testing was performed by assembling the ar-8973r-30-130 arthrex fibulock® nail with an ar-8973-01 outrigger targeting guide batch number: 052029 and an ar-8973-03 attachment screw batch number: 1391911.An ar-8973-17 torque-limiting actuation driver batch number: 131928 was then used to attempt to deploy the talons.It was noted that the torque-limiting actuation driver would not click or mate with the hex of the retention screw.It was then noted that the retention screw was loose within the ar-8973r-30-130 arthrex fibulock® nail.The most likely cause for the reported failure can be attributed to an internal manufacturing issue.

• Brand Name: 3.0X130MM FIBULA NAIL, RIGHT
• 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: 19229458
• Report Number: 1220246-2024-02703
• Device Sequence Number: 6732814
• Product Code: HSB
• UDI-Device Identifier: 00888867295216
• UDI-Public: 00888867295216
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 3.0X130MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-30-130
• Device Lot Number: 15143473
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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