MAUDE Adverse Event Report: ARTHREX, INC. ALL-INSIDE QUADLINK KIT, 10MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	ALL-INSIDE QUADLINK KIT, 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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 11/17/2025, it was reported by a sales representative via (b)(4) that an ar-1288qai-100 quad links flip cutter broke during use.This occurred during use in a case with no patient effect.The broken piece was retrieved without issues.Another kit was opened, and the flip cutter was used without issues.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-1288qai-100, batch 15478186, with a fractured/warped distal end.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to off-axis loading, improper bone preparation, and prying or leveraging the device with excessive force.

• Brand Name: ALL-INSIDE QUADLINK KIT, 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: 23742088
• Report Number: 1220246-2025-05456
• Device Sequence Number: 21370031
• Product Code: GAT
• UDI-Device Identifier: 00888867473553
• UDI-Public: (01)00888867473553(11)250805(17)290430(10)15478186
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/18/2026

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: ALL-INSIDE QUADLINK KIT, 10MM
• Device Catalogue Number: AR-1288QAI-100
• Device Lot Number: 15478186
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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