MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE SUTURE TENSIONER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TIGHTROPE SUTURE TENSIONER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023 it was reported by a sales representative via sems that an ar-1588h tightrope® suture tensioner broke.This occurred during a case when tightening they broke.There was no additional information provided, additional information has been requested.Additional information was provided on 06/26/2023, it was reported that this event occurred during an acl reconstruction on (b)(6) 2023.All fragments were retrieved from the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 a most likely cause.The most likely cause for the reported failure can be attributed to user-applied excessive force during the tightening process.

• Brand Name: TIGHTROPE SUTURE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17329719
• Report Number: 1220246-2023-07177
• Device Sequence Number: 5537383
• Product Code: MDM
• UDI-Device Identifier: 00888867019546
• UDI-Public: 00888867019546
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/26/2025

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: TIGHTROPE SUTURE TENSIONER
• Device Catalogue Number: AR-1588H
• Device Lot Number: 20641248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown