MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MICRO CORKSCREW FT; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/26/2024
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
It was reported by the customer on (b)(6) 2024 that the customer was implanted the device ar-1318rt and now has an allergic reaction.This was noticed after the surgery.The material specifications were forwarded to the attending surgeon.No further information received.Update dw 19-nov-2024: further information was provided that the initial surgery was performed on (b)(6) 2024.It was further reported that the allergic reaction was noticed at the scar of the right thumb where the device was implanted.No further information are currently available.
Event or Problem Description
Update kpilz 04-feb-2025: further information was provided that the revision surgery was performed on (b)(6) 2025.The anchor including the suture material was removed.When the wound on the thumb has healed further tests will be performed.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 patient-specific event.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 20863494
• Report Number: 1220246-2024-08730
• Device Sequence Number: 8592171
• Product Code: HWC
• UDI-Device Identifier: 00888867008519
• UDI-Public: (01)00888867008519(11)231110(17)281031(10)15165969
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 15165969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided; 08/12/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/19/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown