MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, SUTURELOC; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLANT SYSTEM, SUTURELOC
Medical Device Problem Codes	Break (1069); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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 04/28/2025, a sales representative reported via email that an ar-4551 sutureloc malfunctioned during a lateral meniscus transplant procedure.To complete the case, a second ar-4551 sutureloc was opened and used.A photo was provided, and no additional details were provided regarding the malfunction.This was discovered during a lateral meniscus transplant procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 5/22/2025: during the procedure, an ar-4551 sutureloc device malfunctioned when the sheath began to splice, causing it to bunch up irregularly.The malfunction occurred inside the patient, resulting in pieces of the implant breaking.However, all broken pieces were successfully removed from the patient.An additional 15 minutes of anesthesia was required due to the case delay at this time, there are no reported negative effects or significant damage to the patient post-surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-4551, with batch number 15411113, revealed that the sutures were damaged.Therefore, arthrex was able to deduce the cause of the complaint as misuse, due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: IMPLANT SYSTEM, SUTURELOC
• 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: 22061140
• Report Number: 1220246-2025-02139
• Device Sequence Number: 15362263
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: (01)00888867425316(11)250327(17)300131(10)15411113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223284
• 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,Followup
• Report Date (Section B): 10/08/2025

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: IMPLANT SYSTEM, SUTURELOC
• Device Catalogue Number: AR-4551
• Device Lot Number: 15411113
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided; 10/08/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown