MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH,CRKSCRW
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a patient's legal representative reported via email that the patient sustained severe and permanent injuries, including a closed, displaced radial-head and neck fracture, left closed posterolateral elbow dislocation, and a left elbow lateral ulnar collateral ligament tear as the result of an incident involving a bike crash.The patient required an orif procedure; however, the legal representative reported that the procedure was unsuccessful due to a failed ar-1915sf 3.5 x 12.1 mm corkscrew suture anchor.As a result, the patient ultimately underwent an arthroplasty procedure.No further information has been provided.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 6/26/2025: an fda medwatch notification was received via email.A facility representative reported that the patient fell off a bicycle and sustained a left posterolateral elbow dislocation along with additional injuries.In 2024, the patient underwent open reduction and internal fixation of a closed, displaced fracture of the radial head/neck.Procedures also included primary repair of the lateral ulnar collateral ligament using local tissue and open treatment of the elbow dislocation.During surgery, a radial head fracture fragment was excised, and the remaining radial head was anatomically reduced and stabilized using a 2.4mm locking compression plate.The lateral ulnar collateral ligament was repaired utilizing a metal anchor and fiberwire.A ct scan performed in 2025 revealed progressive displacement of volar fragments that were not included in the initial fixation.Additional concerns were raised regarding potential loosening or infection at the lateral epicondyle anchor site, along with the presence of small bony fragments in the posterolateral aspect of the elbow.
Additional Manufacturer Narrative
Additional information: d2a, d2b, 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 is a patient-specific event due to the loosening of the anchor postoperatively.

• Brand Name: SUTR ANCH,CRKSCRW
• 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: 22398883
• Report Number: 1220246-2025-02735
• Device Sequence Number: 17343241
• Product Code: MBI
• UDI-Device Identifier: 00888867022652
• UDI-Public: (01)00888867022652(11)240222(17)290131(10)15211235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SF
• Device Lot Number: 15211235
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 10/09/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/23/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown