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

Model Number	HINDFOOT NAIL CABLE TENSIONER
Medical Device Problem Codes	Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/9/2024, it was reported by a sales representative via email that an arthrex loaner tray was received a couple of days before the surgery took place on (b)(6) 2024.It was verified that the 9091-02 hindfoot nail cable tensioner was in a zeroed-out position before being sterilized.About thirty minutes before the surgery, it was verified again that the 9091-02 hindfoot nail cable tensioner was in a zeroed-out position.During the procedure, when the technician went to tighten down the set screw with the hex driver, the driver immediately began torquing without actually tightening the screw itself.The technician tried to loosen the set screw, but it was proving very difficult to lefty loosey the screw even after the first couple of turns.It was attempted again to tighten the screw down again now, and it immediately clicked due to the torque limiting feature on the hex driver like last time.The cable tensioner was also able to be pulled freely on that side despite the torque limiter clicking like it was fully seated.The other side was attempted to be tightened, but the same issue was happening.After about five minutes, the surgeon noticed the set screws were very elevated and that it looked like only a little bit of the screw was inside of the hole.The surgeon attempted to tighten the down, but the torque limiting feature started clicking immediately, and could not get the screw tightened.The surgeon fully removed both sets of screws, and before re-inserting them, it was noticed that the holes were very far up the oblong window of the tensioner and that no matter what angle he went in at with the screw, it could never get it to go straight into the hole since the plastic was going to block.At this point, the t-handle was on the cable tensioner to lower the holes from those screws down the window, re-insert the set screws, and zero it out again but no matter how hard the surgeon tried the t-handle could not be moved to the inner portion the surgeon, the scrub tech, and both residents tried as hard as possible to move the t-handle but it wouldn¿t budge.The second resident even attempted to turn it in both the right and left directions just to be sure, but to no avail.This process had been going on for about 20-30 minutes, and due to the health concerns of the patient and the time already spent in the procedure, the surgeon made the decision to abandon the nail in place of an ankle fusion plate and screws.An anterior tt plate and 7.0 comp ft screws were used from the ankle fusion set to complete the case.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 12/18/2024: the ttc nail that was not used was discarded.More anesthesia was administered to the patient due to the time added and subsequent need to put a plate to complete the case.This was discovered during an ankle fusion procedure (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted an ar-9091-02 hindfoot nail cable tensioner with over-loosened set screws.It was further noted that the device was stuck/sticking.Refer to attachments.Based on the information provided which may pictures, videos, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to user error and/or mishandling the devices likely from overtightening the cable tensioner with the t-handle and/or over-loosening the set screws.

• Brand Name: HINDFOOT NAIL CABLE TENSIONER
• 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: 21079015
• Report Number: 1220246-2025-09206
• Device Sequence Number: 8443991
• Product Code: HSB
• UDI-Device Identifier: 00888867335301
• UDI-Public: 00888867335301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HINDFOOT NAIL CABLE TENSIONER
• Device Catalogue Number: AR-9091-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 08/27/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/15/2025; 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown