MAUDE Adverse Event Report: ARTHREX, INC.; SMOOTH FIXATION PIN

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

It was reported that 4 months after an initial surgery on (b)(6) 2022 an issue with an implanted tightrope occurred.Due to this failure and additional surgery will be necessary.No information provided by the customer.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that 4 months after an initial surgery on (b)(6) 2022 an issue with an implanted tightrope occurred.Due to this failure and additional surgery will be necessary.No information provided by the customer.Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: UNK
• Type of Device: SMOOTH FIXATION PIN
• 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: 19204552
• MDR Text Key: 341439638
• Report Number: 1220246-2024-02574
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: HR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/29/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1