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

Model Number	SUTURE ANCHOR, PEEK CORKSCREW FT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd july 2024, it was reported by an arthrex employee via email that an ar-1927psf-45, 4.5 mm peek corkscrew® ft suture anchor with one #2 fiberwire® and one # 2 tigerwire®, the head of the anchor was deformed during insertion.This was detected during use in a rotator cuff procedure on (b)(6) 2024.The procedure was completed successfully by using another new ar-1927psf-45, no patient harm and no secondary procedure was needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Visual inspection identified that the implant of the 4.5 mm peek corkscrew® ft suture anchor with one #2 fiberwire® and one # 2 tigerwire® had broken.Functional testing was not performed due to the damage to the device.Per dfu-0087-eo rev 3, section g- precautions: 3.Make sure to use the recommended drill bit or punch to create the bone socket.The most likely cause can be attributed to improper bone preparation, excessive force being used, or prying/leveraging the screw during insertion.

• Brand Name: SUTURE ANCHOR, PEEK 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: 19919607
• Report Number: 1220246-2024-07051
• Device Sequence Number: 8113194
• Product Code: HWC
• UDI-Device Identifier: 00888867023666
• UDI-Public: 00888867023666
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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
• Report Date (Section B): 01/06/2025

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 Model Number: SUTURE ANCHOR, PEEK CORKSCREW FT
• Device Catalogue Number: AR-1927PSF-45
• Device Lot Number: 15164922
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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
• Patient Sex: Unknown