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	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 02/28/2022, it was reported by a sales representative via sems that an ar-1928snf-2 corkscrew suture anchor did not seat.This was discovered during a procedure on 12/20/2021.Additional information received via phone on 2/28/2022: even though the implant had not fully seated, surgeon decided to leave it in and and use it to complete the procedure.Additional information received on 3/16/2022: this was discovered during an achilles haglund removal with secondary achilles repair procedure.

• 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: 19181519
• Report Number: 1220246-2024-02385
• Device Sequence Number: 7298200
• Product Code: HWC
• UDI-Device Identifier: 00888867023789
• UDI-Public: 00888867023789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Expiration Date: 05/31/2022
• Device Model Number: SUTR ANCH,CRKSCRW FT II 5.5X 16.3MM
• Device Catalogue Number: AR-1928SNF-2
• Device Lot Number: 10146637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown