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

Model Number	TIGHTROPE SUTURE TENSIONER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
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 1/9/2024, it was reported by a distributor via (b)(4) that an ar-1588h tightrope suture tensioner had a suture stuck in the handle and could not be removed.This was discovered during an unspecified procedure, with no reported patient harm.Additional information received on 1/24/2024: this was discovered during an acl reconstruction on (b)(6) 2024.The case was completed using another ar-1588h tightrope suture tensioner.There was no adverse effects on the patient due to the issue.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1588h batch number 37621851 was received for evaluation.Visual evaluation confirmed the allegation; a suture is stuck inside the tensioning slot.Functional testing doesn't apply to this device.The most likely cause of the reported failure is wear and damage due to repeated use and/or reprocessing.

• 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: 18614229
• Report Number: 1220246-2024-00638
• Device Sequence Number: 2406662
• Product Code: MDM
• UDI-Device Identifier: 00888867019546
• UDI-Public: 00888867019546
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE SUTURE TENSIONER
• Device Catalogue Number: AR-1588H
• Device Lot Number: 37621851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown