MAUDE Adverse Event Report: ARTHREX, INC. 3.8X180MM FIBULA NAIL, RIGHT; INTRAMED FIXATN ROD AND ACCESS

Model Number	3.8X180MM FIBULA NAIL, RIGHT
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2023
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 9/28/2023, it was reported by a sales representative via email that an ar-8973r-38-180 arthrex fibulock nail talons did not deploy and the activation driver was not seating all the way.The surgeon removed the arthrex fibulock nail and attempted to activate the talons off the jig but was unsuccessful.Another ar-8973r-38-180 arthrex fibulock nail was used to complete the case.This was discovered during a fibulock nail procedure on 9/26/2023.After the procedure, the sales representative put the fibulock nail through the wash and spent about ten to fifteen minutes trying to deploy the talons.Once the talons had deployed, the sales representative noticed that there was a small gray bar or ledge interfering with the driver.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8973r-38-180 arthrex fibulock® nail lot number: 15001947 was received for investigation.Visual evaluation of the device noted that the talons were deployed.Further visual inspection under a magnifier noted that there was debris in the hex of the retention screw and the hex appeared to be damaged as well.Functional testing was performed by assembling the ar-8973r-38-180 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 could not be seated fully against the attachment screw as intended.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.Refer to investigation photos.

• Brand Name: 3.8X180MM 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: emily shafer ; 8009337001
• MDR Report Key: 18005378
• Report Number: 1220246-2023-08377
• Device Sequence Number: 7604136
• Product Code: HSB
• UDI-Device Identifier: 00888867295278
• UDI-Public: 00888867295278
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 3.8X180MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-38-180
• Device Lot Number: 15026297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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