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

Model Number	BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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, an arthrex subsidiary employee reported via email that an ar-2324bcct biocomposite swivelock c, 4.75 mm x 19.1 mm, with blue fibertape loop experienced an issue during insertion.The surgeon noted that no resistance was felt while inserting the anchor, and upon inspection, it was found to be broken.As there was no resistance during placement, the cause of the breakage remains unclear.The case was completed.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 08/27/2025.
Event or Problem Description
Additional information received on 9/4/2025: during tensioning of the swivelock, it broke.All the broken fragments were removed.The case was completed using another ar-2324bcct biocomposite swivelock c.No case delay was reported.No additional anesthesia was administered to the patient.No adverse patient effects were reported during or following the procedure due to this issue.
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 an ar-2324bcct biocomposite swivelock c, 4.75 mm x 19.1 mm, with blue fibertape loop batch number: 15390451 was damaged and broken.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion and/or excessive forces being applied during insertion.

• Brand Name: BIO-COMP, SWIVELOCK C, FT, 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: 23004294
• Report Number: 1220246-2025-03768
• Device Sequence Number: 9413134
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)250217(17)290131(10)15390451
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K101823
• 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: BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCT
• Device Lot Number: 15390451
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/26/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/23/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown