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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrections: h.1 set as n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
Event or Problem Description
Additional information received on 9/27/2024: this was discovered on the back table while prepping the graft.The case was delayed about ten minutes, but additional anesthesia was not needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 9/25/2024, it was reported by a sales representative via email that the tightrope ii from an ar-1588au-cp2 autograft graftlink implant system on the femoral side had the sutures cut at the button while tensioning.This caused the graft to be under tension.The graft was cut out, and a new ar-1588au-cp2 autograft graftlink implant system was used to complete the case.This was discovered during an aclr procedure on 9/25/2024.Additional information received on 9/27/2024: this was discovered on the back table while prepping the graft.The case was delayed about ten minutes, but additional anesthesia was not needed.

• 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: 20358682
• Report Number: 1220246-2024-07970
• Device Sequence Number: 7199298
• Product Code: MBI
• UDI-Device Identifier: 00888867395367
• UDI-Public: (01)00888867395367(11)230414(17)270228(10)15080945
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/07/2024

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: 15080945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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