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	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/24/2023, it was reported by a sales representative via email that an ar-1588au-cp2 autograft graflink implant system was missing the fiberlink.This was discovered upon opening the package during a procedure on (b)(6) 2023.Additional information received on 7/28/2023: this was discoverd during an aclr procedure and completed using an ar-1588btb-2j tightrope ii btb and an ar-1588tn-21 tightrope ii abs.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 a manufacturing issue.Ncr-21345 has been opened to address this issue.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17594543
• Report Number: 1220246-2023-07578
• Device Sequence Number: 12980926
• Product Code: MBI
• UDI-Device Identifier: 00888867395367
• UDI-Public: 00888867395367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• 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): 12/23/2024

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 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: 07/24/2023
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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