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

Model Number	HINDFOOT NAIL CABLE TENSIONER
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via sems (b)(4) that an ar-9091-02 hindfoot nail cable tensioner screw is stripped.It was hard to tighten and loosen.Was damaged when putting it on the jig.As soon as it was placed on the jig it popped off.This was discovered during a procedure with no patient harm.
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.
Additional Manufacturer Narrative
Additional information: complaint is not confirmed.No related problem found.One unpackaged ar-9091-02 was received for evaluation.Visual inspection found that one bolt head and the device's body were damaged.The device was tested with a good set, and no problem was found.The most likely cause(s) for the reported failure is user error, as no problem was found when the device was functionally tested and evaluated with a good set.

• 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: 18997293
• Report Number: 1220246-2024-01710
• Device Sequence Number: 11471368
• Product Code: HSB
• UDI-Device Identifier: 00888867335301
• UDI-Public: 00888867335301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/05/2024

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 CABLE TENSIONER
• Device Catalogue Number: AR-9091-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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