MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK C,4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/16/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2324pslc suture anchor broke.This occurred during the fixation in tibia with fibertape, it occupies a tap (ar-1927d) to make the tunnel, until that moment everything went well, they introduced the eyelet and the first part of the stem but at the moment that the screw entered this one did not enter although it lowered all the green handle, they tried a second time assembling the anchor again and the same thing happened and also part of the screw broke, they continued with another part of the surgery (epm), and when he returned to this fixation they also used a swivelock male and ended up fixing with a titanium tip swivelock and a peek screw, and there was no problem.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer- provided photo noted the anchor of the device was damaged and the eyelet was missing.Refer to attachments.Based on the information provided which may include pictures and the event description, 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 excessive force being used during insertion and/or misaligned insertion.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• 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: 22704668
• Report Number: 1220246-2025-03227
• Device Sequence Number: 13008543
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)241001(17)290930(10)15324813
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K203495
• 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): 09/30/2025

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: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15324813
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 09/26/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/15/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown