MAUDE Adverse Event Report: ARTHREX, INC. DUALCOMP HINDFOOT NAIL, 10.5 X 240 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	DUALCOMP HINDFOOT NAIL, 10.5 X 240 MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
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 sales representative via sems (b)(4) that an ar-9090-03s dual comp hindfoot nail was deployed early.This was discovered during a procedure on (b)(6) /2024.Additional information received on 2/16/2024: this was discovered during a ttc nail procedure.The sales representative had marked that a patient injury occurred; however, after further clarification, it was confirmed that there was no injury to the patient.Nothing broke inside the patient and the case was completed by removing the nail that deployed early and using an ar-9090-02s dual comp hind foot nail.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-9090-03s dualcomp hindfoot nail was received for investigation.Visual evaluation of the device noted significant scratches to the surface of the device.Further visual inspection noted that the peek pin was broken.Functional testing was unable to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied excessive mechanical forces on the impaction rod during insertion.Refer to investigation photos.

• Brand Name: DUALCOMP HINDFOOT NAIL, 10.5 X 240 MM
• 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: 18846113
• Report Number: 1220246-2024-01311
• Device Sequence Number: 7757348
• Product Code: HSB
• UDI-Device Identifier: 00888867305519
• UDI-Public: 00888867305519
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221031
• 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): 09/04/2024

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: DUALCOMP HINDFOOT NAIL, 10.5 X 240 MM
• Device Catalogue Number: AR-9090-03S
• Device Lot Number: 15127486
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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