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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-8973r-30-130 arthrex right fibulock nail talons would not expand or engage with the actuation driver.A new ar-8973r-30-130 arthrex right fibulock nail was used, and the actuation driver engaged immediately.The patient was not affected.This was discovered during an ankle fracture procedure on (b)(6) 2024.The case was delayed three minutes without additional anesthesia administered.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed based on the received condition of the device.One unpackaged ar-8973r-30-130 arthrex fibulock® nail batch number: 151135643 was received for investigation.Visual evaluation noted debris in the hex of the tension screw.The debris was removed and inspected under a magnifier.The debris appeared to be bone matter.Refer to investigation photos.Functional testing was then performed by assembling the returned 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 was able to mate with the hex of the tension screw and actuate the talons as intended.The most likely cause for the reported failure can be attributed to misuse due to the debris in the hex preventing the actuation driver from engaging with the hex of the tension screw.Refer to investigation photos.

• 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: 20161842
• Report Number: 1220246-2024-07443
• Device Sequence Number: 7407260
• Product Code: HSB
• UDI-Device Identifier: 00888867295216
• UDI-Public: 00888867295216
• 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): 01/02/2025

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: 15151445
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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