MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, ALLOGRAFT GRAFTLINK CP 2; MANUAL INSTR, GENERAL SURGICAL

Model Number	IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/09/2025, it was reported by a sales representative via (b)(4) that an ar-1588al-cp2 allograft graftlink the flipcutter made a metal snapping sound and the outside of the drill bit detached from the inside.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 22395904
• Report Number: 1220246-2025-02726
• Device Sequence Number: 17349841
• Product Code: MBI
• UDI-Device Identifier: 00888867395350
• UDI-Public: 00888867395350
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• Device Catalogue Number: AR-1588AL-CP2
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown