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

Model Number	SUTURE ANCHOR, PEEK SUTURETAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1934ps suture anchor released from its eyelet.This occurred during use.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Correction: d2a.
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 user error of the device due to prying/leveraging during use.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK
• 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: 21619232
• Report Number: 1220246-2025-00974
• Device Sequence Number: 12438880
• Product Code: MBI
• UDI-Device Identifier: 00888867024168
• UDI-Public: (01)00888867024168(11)230120(17)271231(10)15046805
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 09/12/2025

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 SUTURETAK
• Device Catalogue Number: AR-1934PS
• Device Lot Number: 15046805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided; 09/04/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/03/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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