MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that a patient underwent a procedure where an ar-1928snf-2- suture anchor was implanted.The patient may be experiencing a reaction.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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,CRKSCRW FT II 5.5X 16.3MM
• 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: 18922954
• Report Number: 1220246-2024-01528
• Device Sequence Number: 6410120
• Product Code: HWC
• UDI-Device Identifier: 00888867023789
• UDI-Public: 00888867023789
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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): 04/15/2025

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 FT II 5.5X 16.3MM
• Device Catalogue Number: AR-1928SNF-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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