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

Model Number	IMPLANT SYSTEM, SUTURELOC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
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 4/3/2025, an fda medwatch notification was received via email.A facility representative reported that the tip of the knee scorpion from an ar-4551 broke off in the patient's right knee.The c-arm was brought into the room to visualize and remove the fragment from the patient's knee.The case was completed as usual.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, 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 being used during firing of the needle and/or unsecure grasp of tissue.Dfu-0392-sub-eo gives the following warnings to help avoid needle breakage and potential patient injury: do not resterilize or reuse the scorpion¿ suture passer needle.Avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device and pass in a different area.Ensure a secure grasp of tissue to prevent the needle from buckling under the tissue.Avoid ¿dry¿ repetitive actuations outside the surgical site.Abrasion of the needle surface can occur that may inhibit proper function.
Event or Problem Description
Additional information received on 4/10/2025: this was discovered during a right knee arthroscopy, arthroscopic, arthroscopic medial meniscus posterior root repair procedure.The broken fragment was from the needle tip.The scorpion needle had been used in conjunction with a scorpion hand instrument; however, the part number of the instrument remains unknown.Notably, the scorpion instrumentation itself did not exhibit any damage or malfunction.No further complications were reported, and the procedure was completed successfully.

• 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: 21882348
• Report Number: 1220246-2025-01634
• Device Sequence Number: 8641230
• Product Code: MBI
• UDI-Device Identifier: 00888867425316
• UDI-Public: 00888867425316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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