MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, BUTTON, 8 X 12 MM; SMOOTH FIXATION PIN

Model Number TIGHTROPE ABS, BUTTON, 8 X 12 MM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Foreign Body Reaction (1868)

Event Date 08/01/2019

Event Type  Injury  

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.

Event Description

On 11/17/2023, it was reported by a patient via phone that in (b)(6) 2023, the patient underwent revision surgery to have an ar-1588tb tightrope button removed due to an allergic reaction.The patient was experiencing swelling and pain.The original procedure took place on (b)(6) 2018.The patient is still having issues with the knee and will need a knee replacement.The patient would like to know the material composition of the tightrope button that was removed during the revision surgery.The patient did not have further information to provide.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18360198
• MDR Text Key: 330933629
• Report Number: 1220246-2023-09494
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019621
• UDI-Public: 00888867019621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Device Catalogue Number: AR-1588TB
• Device Lot Number: 10165135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other