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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 1st sep 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-2324bcct, suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with fibertape® loop (blue), its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-2324bcct.There were no patient harm and no secondary procedure 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 of the suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with f ibertape® loop (blue), identified that the screw was broken and damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device 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: 23094468
• Report Number: 1220246-2025-03939
• Device Sequence Number: 9383376
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)240927(17)280831(10)15323730
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/10/2025

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: 15323730
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown