MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 10MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 05/07/2025, a sales representative reported via email that an ar-1288qis-100 quadlink implant system malfunctioned during use.The fibertag tightrope abs implant broke when the surgeon was preparing the graft, and the quadpro harvester was dull and could not cut the quad tendon for harvest.The case was completed, and no patient harm was reported.This was discovered during an autograft quadriceps acl reconstruction procedure.Additional information has been requested on 05/29/2025.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Visual inspection of the quadlink implant system, 10mm noted that the component cutter assembly, 10mm was not returned with the device to verify the sharpness of the cutter rod.Only the component stripper cutter handle was returned.No problem found.Tightrope abs w/fibertag was cut on the blue suture between the loop and needle.Functional testing was not performed due to the damage to the device.Per surgical technique quadpro tendon harvester note 9: once the desired graft length has been stripped, withdraw the quadpro¿ tendon harvester from the incision and retrieve the graft through the graft amputation window by grasping the tagging sutures.Note 11: advance the push rod forward to amputate the graft.Deploying the push rod into the handle using a syringe-type motion will allow for an easy amputation (a).Note: during amputation of the graft, it is important to maintain visualization of the harvested length to ensure the graft is not cut short.The most likely cause of the reported failure is attributed to user error, potentially resulting from either excessive force applied during suture passing or the device coming into contact with a sharp mating component during use.Two related conditions with this case were investigated.

• Brand Name: QUADLINK IMPLANT SYSTEM, 10MM
• 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: 22115917
• Report Number: 1220246-2025-02301
• Device Sequence Number: 19854748
• Product Code: MBI
• UDI-Device Identifier: 00888867344754
• UDI-Public: (01)00888867344754(11)250331(17)280430(10)15412587
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/26/2025

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: QUADLINK IMPLANT SYSTEM, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15412587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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