MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/7/2025, a sales representative reported via phone that an ar-1288qis-90 quadlink implant system, 9mm, had an issue.During an acl reconstruction procedure on (b)(6) 2025, when the product was opened, the tightrope came out faulty out of the box.Upon cinching it down inside the patient, the suture would not tension.The suture was cut, everything was removed from the patient, and no parts of the implant system broke inside the patient.Another ar-1588rtt2 fibertag tightrope ii implant with lot number: 15200468 was used to complete the procedure successfully with no harm to the patient.All parts from the implant system were discarded, but a picture was taken.There was a case delay of 30-40 minutes, and additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6, h11.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-1288qis-90, with batch number 15350084, revealed that the suture system was bunched/damaged.Therefore, arthrex was able to deduce a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.However, the allegation that this happened out of the box cannot be confirmed as the device was used in the field.

• Brand Name: QUADLINK IMPLANT SYSTEM, 9MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: jared engle ; 8009337001
• MDR Report Key: 21433345
• Report Number: 1220246-2025-00590
• Device Sequence Number: 4337273
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: (01)00888867344747(11)241119(17)280831(10)15350084
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 08/25/2025

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: QUADLINK IMPLANT SYSTEM, 9MM
• Device Catalogue Number: AR-1288QIS-90
• Device Lot Number: 15350084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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
• Patient Sex: Unknown