MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/09/2024
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 that a patient experienced an allergic reaction due to the peek material which resulted in wound healing disorder and reaction to the material.No further information received.Update (b)(6) 18-oct-2024: further information was provided that the initial surgery was performed (b)(6) months ago in (b)(6) 2024.The anchor is still implanted in the patient.The patient suffers diffuse pain but there is no clear indication that it comes from the anchor, and therefore the anchor was not removed by now.The surgeon now plans some additional allergic tests.No further information was made available by the customer.
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: SUTR ANCH, DX SWVLK, PEEK, 1/PK, 4.75 MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 20537550
• Report Number: 1220246-2024-08274
• Device Sequence Number: 6641404
• Product Code: MAI
• UDI-Device Identifier: 00888867319912
• UDI-Public: 00888867319912
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 08/13/2025

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, DX SWVLK, PEEK, 1/PK, 4.75 MM
• Device Catalogue Number: AR-8980P-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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