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

Model Number	IMPL SYS, ALLOGRAFT GRAFTLINK CP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 1/6/2023, it was reported by a sales representative via email that the tightrope abs from an ar-1588al-cp allograft graftlink kit, snapped during the final tensioning on the 14mm concave button for tibial fixation.Surgeon had a tibial whipstitch suture attached to the tightrope, which was used to pull tension while the soft tissue screw was inserted.Case was completed successfully without further issues.This was discovered during a procedure on (b)(6) 2023.Additional information received on 1/9/2023: this was discovered during an aclr procedure, and all the broken tightrope was removed from inside the patient.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.

• Brand Name: IMPL SYS, ALLOGRAFT GRAFTLINK CP
• 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: emily shafer ; 8009337001
• MDR Report Key: 18570472
• Report Number: 1220246-2024-00494
• Device Sequence Number: 17897876
• Product Code: HTY
• UDI-Device Identifier: 00888867200654
• UDI-Public: 00888867200654
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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, ALLOGRAFT GRAFTLINK CP
• Device Catalogue Number: AR-1588AL-CP
• Device Lot Number: 14975726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2022
• 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