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	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems-06640999 that an ar-9091-02 hindfoot nail cable tensioner arrived jammed in the central position (half compressed) and was very difficult to get sliding again (had to attach tensioner to the jig and crank very hard, finally broke through the jam).This occurred during a case.There was a lot of play in the jig where the tensioner/jig connected to the ar-9091-01 hindfoot nail targeting guide was separating even though it was supposed to be locked.The distal calc screw and distal tibial screw missed the nail.They had to freehand perfect circles on the tibia, with perfect circles visualized on the nail via x-ray, you could clearly see the jig not lining up with the tibial screw holes.
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 additional information was provided by a sales representative via email who stated that the even took place on (b)(6) 2024.The procedure performed was a ttc fusion.To complete the procedure, they had to make it work by using perfect circles on targeted screw holes.No photos or videos were taken.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-9091-01 batch 5572034 was received for evaluation.Upon visual inspection, signs of wear were evident on the device due to the material appearing faded.The mating part, ar-9091-02, was found to be weakly attached.Additionally, damage was observed on the connector device.The most likely cause(s) for the reported failure is wear and tear over repetitive use.

• 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: 20182323
• Report Number: 1220246-2024-07497
• Device Sequence Number: 8261451
• Product Code: HSB
• UDI-Device Identifier: 00888867335295
• UDI-Public: 00888867335295
• 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,Followup
• Report Date (Section B): 01/15/2025

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: HINDFOOT NAIL TARGETING GUIDE
• Device Catalogue Number: AR-9091-01
• Device Lot Number: 15141766
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 08/26/2024; 12/20/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown