MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, AUTOGRAFT GRAFTLINK CP 2; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPL SYS, AUTOGRAFT GRAFTLINK CP 2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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) 2024, a sales representative reported via phone that an ar-1588au-cp2 autograft graftlink implant system had the tightrope snapped when tensioning.The broken tightrope was removed from the patient, and another of the same product was used to complete the case.There was a five-minute delay in the case.This was discovered during an acl procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: IMPL SYS, AUTOGRAFT GRAFTLINK CP 2
• 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: 21102447
• Report Number: 1220246-2025-09272
• Device Sequence Number: 15667766
• Product Code: MBI
• UDI-Device Identifier: 00888867395367
• UDI-Public: (01)00888867395367(11)221013(17)260731(10)15011458
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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): 06/17/2025

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 Expiration Date: 07/31/2026
• Device Model Number: IMPL SYS, AUTOGRAFT GRAFTLINK CP 2
• Device Catalogue Number: AR-1588AU-CP2
• Device Lot Number: 15011458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2022
• 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