MAUDE Adverse Event Report: ARTHREX, INC. HINDFOOT NAIL TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	HINDFOOT NAIL TARGETING GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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 6/19/2024, a sales representative reported via (b)(4) that an ar-9091-31 hindfoot nail, impaction rod, had the nail inserted in the jig of an ar-9091-01 hindfoot nail targeting guide.While putting it through as instructed, it caused a thread and broke.This was discovered during a procedure, with no reported patient harm.Additional information was received on 6/25/2024: this was discovered during a revision ttc fusion procedure on (b)(6) 2024.The case was completed with the surgeon using their ttc nail.Threads of impaction rod remained in the jig.There was no delay caused by the breakage.No adverse effects on the patient.
Additional Manufacturer Narrative
Correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Complaint allegation is confirmed.One unpackaged ar-9091-01 hindfoot nail targeting guide lot number: 5572034 was received for investigation.Visual evaluation noted that the device was damaged where the impactor pad gets attached, the threads were stripped and there were dents and impaction marks.It was further noted that a piece of the impactor pad remained in the device.Visual evaluation also noted cracks near where the nail attachment arm is inserted.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces when impacting.

• Brand Name: HINDFOOT NAIL TARGETING GUIDE
• 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: 19730050
• Report Number: 1220246-2024-06723
• Device Sequence Number: 18190245
• Product Code: HSB
• UDI-Device Identifier: 00888867335295
• UDI-Public: 00888867335295
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/14/2024

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: HINDFOOT NAIL TARGETING GUIDE
• Device Catalogue Number: AR-9091-01
• Device Lot Number: 5572034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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