MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, AUTOGRAFT GRAFTLINK CP 2; SMOOTH FIXATION PIN

Model Number	IMPL SYS, AUTOGRAFT GRAFTLINK CP 2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that the surgeon used standard technique to use an ar-1588au-cp2 autograft graftlink implant system the entire way through the use of the flipcutter 3.Upon reaming about 1cm or so, the tip sheered off.The broken piece was retrieved from the patient.The case was completed.This was discovered during an acl/pcl reconstruction procedure on (b)(6) 2025.Additional information was received on 01/21/2025: the case was completed using a flipcutter.There was a five-minute delay in the case, with five minutes of added anesthesia administered to the patient.There were no adverse effects on the patient.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the image received from the field.The photos submitted for evaluation depict the distal tip of the device broken off.Consequently, arthrex was able to conclude a most likely cause as the device wasn't returned for evaluation.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: IMPL SYS, AUTOGRAFT GRAFTLINK CP 2
• Common Device Name: SMOOTH FIXATION PIN
• 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: 21344537
• Report Number: 1220246-2025-00334
• Device Sequence Number: 12726074
• Product Code: MBI
• UDI-Device Identifier: 00888867395367
• UDI-Public: (01)00888867395367(11)231010(17)271130(10)15152093
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 04/09/2025

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, AUTOGRAFT GRAFTLINK CP 2
• Device Catalogue Number: AR-1588AU-CP2
• Device Lot Number: 15152093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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