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

Model Number	TIGHTROPE, ABS, IMPLANT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 17th december 2023, it was reported by a sales representative via email that an ar-1588rtt acl fibertag tightrope potentially unthreaded from locking sock when untangled.This was detected on 28th november 2023 during a revision acl with quads graft procedure.8th jan 2024 - the procedure was completed successfully as the tightrope was unstitched from the quad graft and re-stitched with a new implant.12th jan 2024 - the following part numbers were used in the original acl procedure: ar-1588rt, ar-1588tn and ar-1588tb-4.
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
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 was able to conclude that there was no problem found with the devices from the original procedure and/or the most likely cause for the revision surgery can be attributed to a patient-specific event.The complaint allegation is not confirmed.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• 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: 18639741
• Report Number: 1220246-2024-00750
• Device Sequence Number: 12773070
• Product Code: MAI
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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