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
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem 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.
Additional Manufacturer Narrative
The complaint allegation cannot be confirmed as the device was not received for evaluation, and no pictures of the failure were received.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported and observed failure was a patient-specific event.Specifically, the patient-specific event involved an allergic-like reaction.Direction for use.Dfu-0147-2 at revision 0.C.Contraindications.¿ 4.Foreign body reactions.See adverse effects-allergic type reactions.D.Adverse effects.¿ 6.Bio only: allergic-like reactions to pla materials (plla, pldla) have been reported.These reactions have sometimes necessitated the removal of the implant.Patient sensitivity to device materials must be considered prior to implantation.¿ 7.Silicone sensitivity, though very rare, has been reported.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• Common Device Name: 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
• Report Number: 1220246-2023-09494
• Device Sequence Number: 7771288
• Product Code: HTY
• UDI-Device Identifier: 00888867019621
• UDI-Public: 00888867019621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown