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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
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 09/05/2025, an arthrex subsidiary employee reported via email that an ar-2324bcct biocomposite swivelock c vented suture anchor was intended for use in a biceps reinsertion procedure.During insertion into the cannula, the anchor slipped out.It had not yet been placed at the perforation site or tensioned.The pick was observed to be in poor condition, so a second anchor was used to complete the procedure.This was discovered during a procedure on (b)(6) 2025.Additional information has been requested on 09/11/2025.
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 improper bone preparation, misaligned insertion, prying or leveraging the device during insertion, and/or insufficient fixation.

• 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: 23043395
• Report Number: 1220246-2025-03846
• Device Sequence Number: 15910848
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)240927(17)280831(10)15323760
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 15323760
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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